FDA 510(k)

G-Tech Wireless Patch System (WPS)

K-Number: K212954 · 2022-01-10

Decision Date2022-01-10

Product CodeMYE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

G-Tech Wireless Patch System (WPS) is the device name listed in this FDA 510(k) record. The listed applicant is G-Tech Medical. It received FDA 510(k) clearance on 2022-01-10 under 510(k) number K212954. The device is classified under product code MYE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G-Tech Wireless Patch System (WPS)?

G-Tech Wireless Patch System (WPS) is a medical device that received FDA 510(k) clearance on 2022-01-10. The listed applicant is G-Tech Medical. The 510(k) number is K212954.

When did G-Tech Wireless Patch System (WPS) receive FDA 510(k) clearance?

G-Tech Wireless Patch System (WPS) received FDA 510(k) clearance on 2022-01-10, under 510(k) number K212954.

Who is the listed applicant for G-Tech Wireless Patch System (WPS)?

The FDA 510(k) record lists G-Tech Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G-Tech Wireless Patch System (WPS)?

The FDA product code for G-Tech Wireless Patch System (WPS) is MYE.

Related Devices (Code: MYE)

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.