510(k) K943822 ยท EAM Screen, Intensifying, Radiographic
FUJI UM MAMMO SERIES INTENSIFY SCREENS:
| Applicant | Fujifilm Medical System U.S.A., Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Aug 22, 1994 |
| Received | Jun 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943822
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.