510(k) K944485 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
4000 AU ULTRASOUND IMAGING SYSTEM
| Applicant | Biosound, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 24, 1995 |
| Received | Sep 13, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944485
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.