FUJIFILM ENDOSCOPIC CO2 REGULATOR— 510(k) K133976
Substantially EquivalentFujifilm 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.. Device class: 2.
Clearance details
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Product code
- Code FCX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wayne, NJ, US
Recent devices under product code FCX
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