510(k) K053530 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Medison Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Jan 3, 2006 |
| Received | Dec 19, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053530
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.