The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dp-10/dp-20/dp-30 Digital Ultrasonic Diagnostic Imaging System.
| Device ID | K183660 |
| 510k Number | K183660 |
| Device Name: | DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., LTD Keji 12th Road South, Hi-tech Industrial Park Shenzhen, CN 518057 |
| Contact | Jiang Haosen |
| Correspondent | Jiang Haosen Shenzhen Mindray Bio-Medical Electronics Co., LTD Keji 12th Road South, Hi-tech Industrial Park Shenzhen, CN 518057 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-27 |
| Decision Date | 2019-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904030531 | K183660 | 000 |
| 06936415902629 | K183660 | 000 |