FUJIFILM Endoscopic CO2 Regulator GW-100— 510(k) K180711

Name: FDA 510(k) clearance K180711
Creator: U.S. Food and Drug Administration
Published: 2018-05-25

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K180711 for FUJIFILM Endoscopic CO2 Regulator GW-100, Substantially Equivalent on 2018-05-25. Applicant: Fujifilm Corporation. Device class: 2.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code FCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2018-03-19
Decision date: 2018-05-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigara Kami-Gun, JP

Download summary PDF View on FDA.gov ↗

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