510(k) K053084 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
| Applicant | Kontron Medical Systems Sas, Redmond WA, US |
| Decision | Substantially Equivalent, Nov 16, 2005 |
| Received | Nov 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053084
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.