510(k) K980860 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Atlantis Diagnostics Intl., Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Apr 2, 1998 |
| Received | Mar 5, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980860
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.