Air/Water Bottle Tubing, CO2 Source Tubing— 510(k) K231471

Name: FDA 510(k) clearance K231471
Creator: U.S. Food and Drug Administration
Published: 2023-09-08

Substantially Equivalent

Zhejiang Chuangxiang Medical Technology Co., Ltd.

FDA 510(k) clearance K231471 for Air/Water Bottle Tubing, CO2 Source Tubing, Substantially Equivalent on 2023-09-08. Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-05-22
Decision date: 2023-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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