510(k) K002357 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS
| Applicant | Pie Medical, Indianpolis IN, US |
| Decision | Substantially Equivalent, Nov 9, 2000 |
| Received | Aug 2, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002357
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.