510(k) K142982 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
OPUS 5100 Diagnostic Doppler Ultrasound System
| Applicant | Chang Gung Medical Technology Co., Ltd., Taipei City, TW |
| Decision | Substantially Equivalent, Sep 3, 2015 |
| Received | Oct 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142982
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.