Vacutore Air/Water Bottle Tubing— 510(k) K191366

Name: FDA 510(k) clearance K191366
Creator: U.S. Food and Drug Administration
Published: 2019-09-06

Substantially Equivalent

Smartdata Suzhou Co., Ltd.

FDA 510(k) clearance K191366 for Vacutore Air/Water Bottle Tubing, Substantially Equivalent on 2019-09-06. Applicant: Smartdata Suzhou Co., Ltd.. Device class: 2.

Clearance details

Applicant: Smartdata Suzhou Co., Ltd.
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2019-05-22
Decision date: 2019-09-06
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.