FUJI UM MAMMO SERIES INTENSIFY SCREENS:— 510(k) K943822
Substantially EquivalentFujifilm Medical System U.S.A., Inc.
FDA 510(k) clearance K943822 for FUJI UM MAMMO SERIES INTENSIFY SCREENS:, Substantially Equivalent on 1994-08-22. 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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