FIKO FO; , TJER,A; O,AGER FTO-1000— 510(k) K950610
Substantially EquivalentFujifilm Medical System U.S.A., Inc.
FDA 510(k) clearance K950610 for FIKO FO; , TJER,A; O,AGER FTO-1000, Substantially Equivalent on 1995-04-25. Applicant: Fujifilm Medical System U.S.A., Inc.. Device class: 2.
Clearance details
- Device name as filed
- FIKO FO;, TJER,A; O,AGER FTO-1000
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Product code
- Code LMC
- Device class
- Class 2
- Regulation
- 21 CFR 892.2040
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
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