510(k) K981293 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
7200 ULTRASOUND IMAGING SYSTEM
| Applicant | Biosound Esaote, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 30, 1998 |
| Received | Apr 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981293
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.