DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System
FDA 510(k) clearance K183660 · decided 2019-04-09
Clearance details
- K-number
- K183660
- Device name
- DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-12-27
- Decision date
- 2019-04-09
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage recall (Z-1330-2020) | Mindray DS USA, Inc. dba Mindray North America | 2020-02-05 |