510(k) K853116 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
PAXIAL
| Applicant | Biophysic Medical, Inc., Suffield CT, US |
| Decision | Substantially Equivalent, Oct 31, 1985 |
| Received | Jul 25, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853116
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.