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FDA 510(k)

TOP-RANK ADHESIVE ELECTRODE

K-Number: K070612 · 2007-05-07

ApplicantTop-Rank Health Care Equipment Co., Ltd.
Decision Date2007-05-07
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TOP-RANK ADHESIVE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Top-Rank Health Care Equipment Co., Ltd.. It received FDA 510(k) clearance on 2007-05-07 under 510(k) number K070612. 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 TOP-RANK ADHESIVE ELECTRODE?

TOP-RANK ADHESIVE ELECTRODE is a medical device that received FDA 510(k) clearance on 2007-05-07. The listed applicant is Top-Rank Health Care Equipment Co., Ltd.. The 510(k) number is K070612.

When did TOP-RANK ADHESIVE ELECTRODE receive FDA 510(k) clearance?

TOP-RANK ADHESIVE ELECTRODE received FDA 510(k) clearance on 2007-05-07, under 510(k) number K070612.

Who is the listed applicant for TOP-RANK ADHESIVE ELECTRODE?

The FDA 510(k) record lists Top-Rank Health Care Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOP-RANK ADHESIVE ELECTRODE?

The FDA product code for TOP-RANK ADHESIVE ELECTRODE is GXY.

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Other records listing Top-Rank Health Care Equipment Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132588ADHESIVE ELECTRODES

Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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