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FDA 510(k)

LIFECARE ELECTRODES

K-Number: K083302 · 2009-08-03

ApplicantEveryway Medical Instruments Co.,Ltd
Decision Date2009-08-03
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LIFECARE ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2009-08-03 under 510(k) number K083302. 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 LIFECARE ELECTRODES?

LIFECARE ELECTRODES is a medical device that received FDA 510(k) clearance on 2009-08-03. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K083302.

When did LIFECARE ELECTRODES receive FDA 510(k) clearance?

LIFECARE ELECTRODES received FDA 510(k) clearance on 2009-08-03, under 510(k) number K083302.

Who is the listed applicant for LIFECARE ELECTRODES?

The FDA 510(k) record lists Everyway Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFECARE ELECTRODES?

The FDA product code for LIFECARE ELECTRODES is GXY.

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Official Source

View on FDA Database →

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

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