FUJIFILM ENDOSCOPIC CO2 REGULATOR— 510(k) K133976

Substantially Equivalent

Fujifilm Medical System U.S.A., Inc.

FDA 510(k) clearance K133976 for FUJIFILM ENDOSCOPIC CO2 REGULATOR, Substantially Equivalent on 2014-09-09. Applicant: Fujifilm Medical System U.S.A., Inc..

Clearance details

Applicant: Fujifilm Medical System U.S.A., Inc.
Product code: Code FCX
Advisory panel: Gastroenterology, Urology
Date received: 2013-12-26
Decision date: 2014-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

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