510(k) K183041 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Full Digital Colour Doppler Ultrasonic Diagnostic System
| Applicant | Wuhan Zoncare Bio-medical Electronics Co., Ltd., Wuhan, CN |
| Decision | Substantially Equivalent, Jul 10, 2019 |
| Received | Nov 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183041
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.