510(k) K981510 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SONOACE 6000/ ULTRAMARK 400
| Applicant | Medison America, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, May 8, 1998 |
| Received | Apr 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981510
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.