SmartStart Air/Water and Suction Valves— 510(k) K160403

Name: FDA 510(k) clearance K160403
Creator: U.S. Food and Drug Administration
Published: 2016-05-19

Substantially Equivalent

Endochoice, Inc.

FDA 510(k) clearance K160403 for SmartStart Air/Water and Suction Valves, Substantially Equivalent on 2016-05-19. Applicant: Endochoice, Inc.. Device class: 2.

Clearance details

Applicant: Endochoice, Inc.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2016-02-12
Decision date: 2016-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpharetta, GA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.