510(k) K890637 ยท HEM Imager, Ultrasonic Obstetric-Gynecologic
EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE
| Applicant | Elscint, Inc., Hackensack NJ, US |
| Decision | Substantially Equivalent, Jun 12, 1989 |
| Received | Feb 8, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890637
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.