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Application for Further Review of Protest No. 3901-23-128434; Classification of Pulse Oximeters
HQ H338599 July 2, 2024 OT:RR:CTF:EMAIN H338599 MFT CATEGORY: Classification TARIFF NO.: 9018.19.95 Center Director, Pharmaceuticals, Health and Chemicals C.E.E. Service Port of Chicago Chicago O’Hare International Airport, Terminal 55 10000 Bessie Coleman Drive Chicago, IL 60666 Re: Application for Further Review of Protest No. 3901-23-128434; Classification of Pulse Oximeters Dear Center Director: The following is our decision on the Application for Further Review (AFR) of Protest No. 3901-23-128434, which was filed on February 7, 2023, on behalf of Veridian Healthcare, LLC (Protestant). The protest pertains to the classification under the Harmonized Tariff Schedule of the United States (HTSUS) by U.S. Customs and Border Protection (CBP) of certain pulse oximeters. FACTS: The merchandise at issue consists of certain pulse oximeters from China. The subject pulse oximeters are used to measure the concentration of oxygen in blood, specifically oxygen saturation of arterial hemoglobin (SpO2). The protestant indicates that calculations from the subject pulse oximeters “can be used by the healthcare provider to decide if a person needs to seek medical attention and may need extra oxygen.” The pulse oximeters clip onto a user’s fingertip and take non-invasive measurements. Infrared light emits from one side of the clip, transmits through the user’s capillaries in the finger, and is received by a receptor on the other side of the clip. Color changes that occur over time represent oxygenation levels, which is calculated and displayed as functional oxygen saturation. The device also displays a user’s pulse rate in beats per minute (bpm). The subject pulse oximeters operate with an SpO2 accuracy of a root-mean square difference of less than or equal to 4.0% over the range of 70% to 100% of oxygenated hemoglobin (SaO2). The protestant indicates that these results were confirmed by a controlled desaturation study, which examined blood oxygen saturation levels compared to arterial CO-oximetry. Further, the protestant demonstrates that the subject pulse oximeters are accurate under conditions of low perfusion at 0.4%, and that the merchandise displays pulse rate data over a range of 30 to 250 bpm +/- 2 bpm. The subject pulse oximeters are not equipped with an alarm; they are not intended for use in laboratory research applications, ambulances, or air transport; and they do not require a blood sample from a patient. The pulse oximeters also provide a warning to the user when the signal is inadequate. The subject merchandise was entered from November 12, 2021, through August 14, 2022, under heading 9018, HTSUS, which provides for, “Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof.” CBP liquidated the merchandise from October 28, 2022, through December 16, 2022, under heading 9029, HTSUS, which provides for “Revolution counters, production counters, taximeters, odometers, pedometers and the like; speedometers and tachometers, other than those of heading 9014 or 9015; stroboscopes; parts and accessories thereof.” ISSUE: Whether the subject pulse oximeters are classified under heading 9018, HTSUS, as “instruments used in medical sciences,” or under heading 9029, HTSUS, as “tachometers.” LAW AND ANALYSIS: This matter is protestable under 19 U.S.C. § 1514(a)(2) as it regards a CBP decision on classification. This protest was timely filed, within 180 days of liquidation of the first entry. Further review of this protest is properly accorded to the protestant pursuant to 19 C.F.R. § 174.24(a) because the protestant alleges that CBP’s liquidation of the subject merchandise under heading 9029, HTSUS, is inconsistent with prior CBP decisions with respect to the same or substantially similar merchandise. Specifically, the protestant claims CBP failed to follow New York Ruling Letter (NY) N144735 (Feb. 11, 2011) where we classified a certain pulse oximeter from China under heading 9018, HTSUS. Classification under the HTSUS is in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods will be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 will then be applied in order. The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the Harmonized System and are generally indicative of the proper interpretation of the heading. The HTSUS headings under consideration are as follows: 9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof: * * * * * 9029 Revolution counters, production counters, taximeters, odometers, pedometers and the like; speedometers and tachometers, other than those of heading 9014 or 9015; stroboscopes; parts and accessories thereof: The resolution of this case rests on GRI 1. To be classified under this rule, the subject merchandise must meet the terms of either heading 9018, HTSUS, as “instruments used in medical sciences,” or heading 9029, HTSUS, as “tachometers.” If one heading describes the subject merchandise in whole, we must apply that heading and end our analysis. In conducting this analysis, we observe the well-established principle that “in order to produce uniformity in the imposition of duties, the dutiable classification of articles imported must be ascertained by an examination of the imported article itself, in the condition in which it is imported.” We note that neither the HTSUS nor the ENs define the term “tachometer.” Courts have found that in the absence of a definition of a term in the HTSUS or ENs, the term’s correct meaning is its “common and commercial meaning.” The common and commercial meaning may be determined by consulting dictionaries, lexicons, scientific authorities, and other reliable sources. A previous CBP ruling examined the term “tachometer” and found that it included certain articles that measure a person’s pulse rate. In Headquarters Ruling Letter (HQ) 087550 (Feb. 28, 1991), we concluded that “[t]here is ample support for the position that articles which measure pulse and heart rate are specialized types of tachometers described as hemotachometers and cardiotachometers.” In particular: The Random House Dictionary of the English Language, Random House, Inc. (1973), defines "tachometer" as follows: 1. any of various instruments for measuring or indicating velocity or speed, as of a machine, a river, the blood, etc. . . . The International Dictionary of Medicine and Biology, John Wiley & Sons (1986), defines "tachometer" as follows: An instrument that measures speed or rate, such as a cardiotachometer . . . Stedman's Medical Dictionary, 23rd Ed., Williams & Wilkins Company (1976) defines "tachometer" as follows: An instrument for measuring the speed or rate of something; e.g., revolutions of a shaft, heart rate (cardiotachometer), arterial blood flow (hemotachometer) . . . See also Taber's Cyclopedic Medical Dictionary, 14th Ed., F. A. Davis Company (1981); Gould's Medical Dictionary, 5th Ed., The Blakiston Company (1941). Taking these definitions into account, we found that the common and commercial meaning of the term “tachometer” under heading 9029, HTSUS, included certain instruments that measure or indicate speed, velocity, or rate – including medical instruments that measure or indicate a
This matter is protestable under 19 U.S.C. § 1514(a)(2) as it regards a CBP decision on classification. This protest was timely filed, within 180 days of liquidation of the first entry. Further review of this protest is properly accorded to the protestant pursuant to 19 C.F.R. § 174.24(a) because the protestant alleges that CBP’s liquidation of the subject merchandise under heading 9029, HTSUS, is inconsistent with prior CBP decisions with respect to the same or substantially similar merchandise. Specifically, the protestant claims CBP failed to follow New York Ruling Letter (NY) N144735 (Feb. 11, 2011) where we classified a certain pulse oximeter from China under heading 9018, HTSUS. Classification under the HTSUS is in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods will be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 will then be applied in order. The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the Harmonized System and are generally indicative of the proper interpretation of the heading.The HTSUS headings under consideration are as follows:9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments; parts and accessories thereof:* * * * *9029 Revolution counters, production counters, taximeters, odometers, pedometers and the like; speedometers and tachometers, other than those of heading 9014 or 9015; stroboscope