KYOKKO UM SERIES INTENSIFYING SCREEN— 510(k) K942399
Substantially EquivalentFujifilm Medical System U.S.A., Inc.
FDA 510(k) clearance K942399 for KYOKKO UM SERIES INTENSIFYING SCREEN, Substantially Equivalent on 1994-06-10. Applicant: Fujifilm Medical System U.S.A., Inc.. Device class: 1.
Clearance details
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Product code
- Code EAM
- Device class
- Class 1
- Regulation
- 21 CFR 892.1960
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
Recent devices under product code EAM
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