Andorate Auxiliary Water Connector, Andorate Valves Set— 510(k) K191231

Name: FDA 510(k) clearance K191231
Creator: U.S. Food and Drug Administration
Published: 2019-06-07

Substantially Equivalent

Smartdata Suzhou Co., Ltd.

FDA 510(k) clearance K191231 for Andorate Auxiliary Water Connector, Andorate Valves Set, Substantially Equivalent on 2019-06-07. Applicant: Smartdata Suzhou Co., Ltd.. Device class: 2.

Clearance details

Applicant: Smartdata Suzhou Co., Ltd.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2019-05-08
Decision date: 2019-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, 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.