510(k) K771816 ยท HEM Imager, Ultrasonic Obstetric-Gynecologic
ROCHE AXISCAN 5
| Applicant | Roche Medical Electronics, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 19, 1977 |
| Received | Sep 27, 1977 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K771816
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.