510(k) K991671 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Advanced Technology Laboratories, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Jun 18, 1999 |
| Received | May 17, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991671
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.