510(k) K092837 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
OTI-SCAN 3000
| Applicant | Opko Instrumentation, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Dec 23, 2009 |
| Received | Sep 15, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092837
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.