510(k) K961459 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
LEVEL 10 HDI
| Applicant | Advanced Technology Laboratories, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Mar 26, 1997 |
| Received | Apr 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961459
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.