510(k) K801060 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE
| Applicant | Smithkline Diagnostics, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jun 4, 1980 |
| Received | May 6, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801060
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.