H337761

HQ H337761 June 18, 2024 OT:RR:CTF:EMAIN H337761 MFT CATEGORY: Classification TARIFF NO.: 9018.19.95 Center Director – Pharmaceuticals, Health and Chemicals C.E.E. Port of Cincinnati 4243 Olympic Blvd., Suite 210 Erlanger, KY 41018 ATTN: Ms. Leslie Holmes, Supervisory Import Specialist Re: Application for Further Review of Protest No. 4197-22-105721; Classification of the FL 350 and FL 400 Pulse Oximeters from China Dear Center Director: The following is our decision on the Application for Further Review (AFR) of Protest No. 4197-22-105721, which was filed on August 22, 2022, by counsel on behalf of Lorte Technologies, Inc. (Protestant). The protest pertains to U.S. Customs and Border Protection’s (CBP) classification under the Harmonized Tariff Schedule of the United States (HTSUS) of certain pulse oximeters. FACTS: The subject merchandise consists of two models of pulse oximeters from China: the “FL 350” and the “FL 400.” These pulse oximeters are designed to readily examine the oxygen saturation of arterial hemoglobin and the pulse rate of patients at home and in clinical environments. The information provided by the pulse oximeters, alone, cannot form the basis for a diagnosis; rather, it must be read together with other clinical information to determine if the blood is well oxygenated. The internal components of the FL 350 include: a printed circuit board assembly (PCBA); thin film transistor (TFT) screen; LED; sensor; microcontroller unit (MCU); resistor; capacitor; button; and bare printed circuit board (PCB). The external components include an outer shell, a pad that attaches to the finger, a screen protection panel, and springs. The internal components of the FL 400 consist of: a PCBA; LED screen; LED; sensor; MCU; resistor; capacitor; button; and bare PCB. Its external components include an outer shell, a pad that attaches to the finger, a screen protection panel, and springs. For each device, the MCU includes software for receiving and processing sensor data and producing the output on the screen. Each pulse oximeter is calibrated to display functional arterial oxygen saturation (SpO2). The pulse oximeters do not require a blood sample from the patient; rather, each device clamps to a user’s finger and measures SpO2 levels and the pulse rate in beats per minute (bpm) via the sensor. The pulse oximeters are not intended for use in laboratory research applications, nor in ambulances or air transport. Each pulse oximeter operates 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). To validate its accuracy, each pulse oximeter underwent a controlled desaturation study that involved clinical testing of volunteers and comparing values obtained by the subject oximeters’ SpO2 measurements with those found via secondary standard pulse oximeter equipment. Moreover, each pulse oximeter provides pulse rate data with measurements between 30 bpm to 250 bpm with an accuracy of ±2 bpm during the pulse rate range of 30 bpm ~ 99 bpm, and ±2% during the pulse rate range of 100 bpm to 250 bpm. Neither device is equipped with an alarm. If the pulse oximeters fail to register a signal, the device will provide a warning to the operator indicating signal inadequacy. The subject merchandise was entered between January 14, 2022, and June 22, 2022. The protestant entered the merchandise under heading 9018, HTSUS, specifically subheading 9018.19.95, 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: Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters); parts and accessories thereof: Other: Other: Other.” CBP liquidated the subject merchandise under primary heading 9029, HTSUS, specifically subheading 9029.20.40, HTSUS, which provides for “Revolution counters, production counters, taximeters, odometers, pedometers and the like; speedometers and tachometers, other than those of heading 9014 or 9018; stroboscopes; parts and accessories thereof: Speedometers and tachometers; stroboscopes: Other speedometers and tachometers.” In support of its proposed classification, the protestant claims that the subject pulse oximeters “are unambiguously articles ‘used in medical . . . sciences” and presents certain documents from the Food and Drug Administration (FDA). These documents include information from the FDA’s Global Unique Device Identification Database (GUDID), a system that is used “to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use,” as well as FDA registration information. Additionally, the protestant notes that the subject pulse oximeters have obtained 510(k) clearance from the FDA. “This,” the protestant claims, “means that the company [i.e., Lorte Technologies, Inc.] registered and notified the FDA of [Lorte’s] intent to market a medical device, and that based on similar devices on the market, the FDA gave clearance to market [Lorte’s] product as a medical device on the market.” 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 pulse oximeters under heading 9029, HTSUS, is inconsistent with its rulings on similar fingertip oximeters. Specifically, the protestant points to New York Ruling Letter (NY) N144735 in which we found that a certain pulse oximeter from China was classifiable 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 9018; stroboscopes; parts and accessories thereof. This matter turns on the application of GRI 1, specifically whether the subject merchandise meets the terms of heading 9018, HTSUS, as “instruments used in medical sciences” or the terms of heading 9029, HTSUS, as a “tachometer.” It is a well-established principle “that statutes, regulations, and administrative interpretations not related to tariff purposes are not determinative of customs classification disputes.” It is also well-established that “in order to produce uniformity in the imposition of duties, the dutiable classi

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 pulse oximeters under heading 9029, HTSUS, is inconsistent with its rulings on similar fingertip oximeters. Specifically, the protestant points to New York Ruling Letter (NY) N144735 in which we found that a certain pulse oximeter from China was classifiable 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 9018; stroboscopes; parts and accessories thereof. This matter tur