510(k) K003775 ยท IYX Camera, Scintillation (Gamma)
PORTABLE BREAST COMPRESSION DEVICE
| Applicant | Pem Technologies, Rockville MD, US |
| Decision | Substantially Equivalent, Jan 12, 2001 |
| Received | Dec 6, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003775
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.