510(k) K862627 ยท HEM Imager, Ultrasonic Obstetric-Gynecologic
SONORANGER TRANSVAGINAL PROBE
| Applicant | Ausonics Pty , Ltd., Suffield CT, US |
| Decision | Substantially Equivalent for Some Indications, Aug 1, 1986 |
| Received | Jul 10, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862627
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.