Single Use Endoscope Valves Set— 510(k) K192048

Name: FDA 510(k) clearance K192048
Creator: U.S. Food and Drug Administration
Published: 2020-05-14

Substantially Equivalent

Anrei Medical (Hangzhou) Co., Ltd.

FDA 510(k) clearance K192048 for Single Use Endoscope Valves Set, Substantially Equivalent on 2020-05-14. Applicant: Anrei Medical (Hangzhou) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Anrei Medical (Hangzhou) Co., Ltd.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2019-07-31
Decision date: 2020-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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