510(k) K881329 ยท HEM Imager, Ultrasonic Obstetric-Gynecologic
FETAL DOPPLER FOR ULTRAMARK 4 AND 8
| Applicant | Advanced Technology Laboratories, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Apr 14, 1989 |
| Received | Mar 30, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881329
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.