FDA 510(k)

FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE

K-Number: K110289 · 2011-08-30

ApplicantXian Friendship Medical Electronics Co., Ltd.

Decision Date2011-08-30

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Xian Friendship Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2011-08-30 under 510(k) number K110289. 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 FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE?

FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE is a medical device that received FDA 510(k) clearance on 2011-08-30. The listed applicant is Xian Friendship Medical Electronics Co., Ltd.. The 510(k) number is K110289.

When did FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE receive FDA 510(k) clearance?

FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE received FDA 510(k) clearance on 2011-08-30, under 510(k) number K110289.

Who is the listed applicant for FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE?

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

What is the FDA product code for FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE?

The FDA product code for FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE 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.