Disposable Valve Sets— 510(k) K192258

Name: FDA 510(k) clearance K192258
Creator: U.S. Food and Drug Administration
Published: 2019-12-30

Substantially Equivalent

Zhejiang Chuangxiang Medical Technology Co., Ltd.

FDA 510(k) clearance K192258 for Disposable Valve Sets, Substantially Equivalent on 2019-12-30. Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2019-08-20
Decision date: 2019-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hanzhou, CN

Download summary PDF View on FDA.gov ↗

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