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FDA 510(k)

SELF-ADHESIVE ELECTRODES

K-Number: K080276 · 2008-08-04

ApplicantCathay Health Care Equipment Manufacturing, Inc.
Decision Date2008-08-04
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SELF-ADHESIVE ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Cathay Health Care Equipment Manufacturing, Inc.. It received FDA 510(k) clearance on 2008-08-04 under 510(k) number K080276. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELF-ADHESIVE ELECTRODES?

SELF-ADHESIVE ELECTRODES is a medical device that received FDA 510(k) clearance on 2008-08-04. The listed applicant is Cathay Health Care Equipment Manufacturing, Inc.. The 510(k) number is K080276.

When did SELF-ADHESIVE ELECTRODES receive FDA 510(k) clearance?

SELF-ADHESIVE ELECTRODES received FDA 510(k) clearance on 2008-08-04, under 510(k) number K080276.

Who is the listed applicant for SELF-ADHESIVE ELECTRODES?

The FDA 510(k) record lists Cathay Health Care Equipment Manufacturing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELF-ADHESIVE ELECTRODES?

The FDA product code for SELF-ADHESIVE ELECTRODES is GXY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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