510(k) K003141 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
UBM PLUS, MODEL P45
| Applicant | Paradigm Medical Industries, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Dec 5, 2000 |
| Received | Oct 10, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003141
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.