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NY I81222




May 15, 2002

CLA-2-90:RR:NC:N1:105 I81222

CATEGORY: CLASSIFICATION

TARIFF NO.: 9018.19.9550

Mr. Christian Wagner
CNSystems Medizintechnik GmbH
Baumkircherstrasse 1
Europe, Austria, 8020 Graz

RE: The tariff classification of Task Force Monitor 3040 from Austria

Dear Mr. Wagner:

In your letter, no sample, dated April 26, 2002, you requested a tariff classification ruling.

You state: “The device is called Task Force Monitor 3040 (TFM) which has already a FDA 510(k) (K014063) clearance. The TFM is intended to noninvasively measure and display a patient’s hemodynamic parameters using impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure (contBP). The TFM monitors continuously the subject’s hemodynamic parameters without reporting any diagnosis. The device is not designed for vital sign monitoring or self-monitoring of patients.”

The brochure indicates that the generation of an automatic report of cardiac parameters is a major function.

We do not agree that 9018.19.40 applies since we believe “exploratory examination” implies a more invasive, hands-on method. HRL 961705, 8-25-99, noted.

It does not perform the continuous monitoring of vital signs and the generation of alarms due to variations that is needed, for example, in an Intensive Care Unit.

The applicable subheading for the TFM will be 9018.19.9550, Harmonized Tariff Schedule of the United States (HTS), which provides for “other” Instruments and appliances used in medical, surgical, dental or veterinary sciences - Electro-diagnostic apparatus (including apparatus for functional exploratory examination or for checking physiological parameters). The rate of duty will be free

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist J. Sheridan at 646-733-3012.

Sincerely,

Robert B. Swierupski
Director,

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