The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dc-90/dc-90s/dc-90q/dc-95/dc-95s/dc-88/dc-88s/dc-80a/dc-80a Exp/dc-80a Pro/dc-8x/dc-8q/dc-81/dc-82 Diagnostic Ultrasound System.
| Device ID | K190206 |
| 510k Number | K190206 |
| Device Name: | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 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 | Zhang Wei |
| Correspondent | Zhang Wei 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 |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-04 |
| Decision Date | 2019-03-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06936415919207 | K190206 | 000 |
| 06936415903879 | K190206 | 000 |
| 06936415903633 | K190206 | 000 |
| 06936415919238 | K190206 | 000 |
| 06944904088600 | K190206 | 000 |