andorate Suction Valve, andorate Air/Water Valve— 510(k) K213095

Name: FDA 510(k) clearance K213095
Creator: U.S. Food and Drug Administration
Published: 2022-01-12

Substantially Equivalent

Ga Health Company Limited

FDA 510(k) clearance K213095 for andorate Suction Valve, andorate Air/Water Valve, Substantially Equivalent on 2022-01-12. Applicant: Ga Health Company Limited. Device class: 2.

Clearance details

Applicant: Ga Health Company Limited
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2021-09-24
Decision date: 2022-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

Download summary PDF View on FDA.gov ↗

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