510(k) K851902 ยท HEM Imager, Ultrasonic Obstetric-Gynecologic
MODEL U-1000 ULTRASONIC SCANNER
| Applicant | Fukuda Denshi USA, Inc., Kirkland WA, US |
| Decision | Substantially Equivalent, Sep 27, 1985 |
| Received | Apr 30, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851902
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.