510(k) K063580 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Medison Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Dec 14, 2006 |
| Received | Nov 30, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063580
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.