G-Tech Wireless Patch System (WPS)— 510(k) K212954

Name: FDA 510(k) clearance K212954
Creator: U.S. Food and Drug Administration
Published: 2022-01-10

Substantially Equivalent

G-Tech Medical

FDA 510(k) clearance K212954 for G-Tech Wireless Patch System (WPS), Substantially Equivalent on 2022-01-10. Applicant: G-Tech Medical. Device class: 2.

Clearance details

Applicant: G-Tech Medical
Product code: Code MYE
Device class: Class 2
Regulation: 21 CFR 876.1735
Advisory panel: Gastroenterology, Urology
Date received: 2021-09-16
Decision date: 2022-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.