510(k) K183660 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Apr 9, 2019 |
| Received | Dec 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183660
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2020 | Mindray DS USA, Inc. dba Mindray North America DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patient Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.