510(k) K102989 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS
| Applicant | Chang Gung Medical Technology Co., Ltd. Linkou Fac, Dublin CA, US |
| Decision | Substantially Equivalent, Dec 9, 2010 |
| Received | Oct 6, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102989
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.