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FDA 510(k)

Adhesive Electrodes

K-Number: K170744 · 2017-05-08

ApplicantReno Medical , Ltd.
Decision Date2017-05-08
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Adhesive Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Reno Medical , Ltd.. It received FDA 510(k) clearance on 2017-05-08 under 510(k) number K170744. 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 Adhesive Electrodes?

Adhesive Electrodes is a medical device that received FDA 510(k) clearance on 2017-05-08. The listed applicant is Reno Medical , Ltd.. The 510(k) number is K170744.

When did Adhesive Electrodes receive FDA 510(k) clearance?

Adhesive Electrodes received FDA 510(k) clearance on 2017-05-08, under 510(k) number K170744.

Who is the listed applicant for Adhesive Electrodes?

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

What is the FDA product code for Adhesive Electrodes?

The FDA product code for Adhesive Electrodes is GXY.

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

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