The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dc-30/dc-32/dc-28/dc-26/dc-25/dc-20/dc-30 Exp/dc-32 Exp Diagnostic Ultrasound System.
| Device ID | K201990 |
| 510k Number | K201990 |
| Device Name: | DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound 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 Mindray Building, Keji 12th Road South, Hi-tech Industrial Park Nanshan, 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 | 2020-07-17 |
| Decision Date | 2020-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06936415972196 | K201990 | 000 |
| 06936415972189 | K201990 | 000 |
| 06936415972172 | K201990 | 000 |
| 06936415911256 | K201990 | 000 |
| 06936415911232 | K201990 | 000 |