The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd. with the FDA for Mx7/mx7t/vaus7/zeus/me7/anesus Me7/anesus Me7t/mx8/mx8t/vaus8/me8 Diagnostic Ultrasound System.
| Device ID | K212900 |
| 510k Number | K212900 |
| Device Name: | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 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 | Shi Jufang |
| Correspondent | Shi Jufang 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 | 2021-09-13 |
| Decision Date | 2021-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06936415974466 | K212900 | 000 |
| 06936415925772 | K212900 | 000 |
| 06936415925789 | K212900 | 000 |
| 06936415926571 | K212900 | 000 |
| 06936415926601 | K212900 | 000 |
| 06936415926625 | K212900 | 000 |
| 06936415926694 | K212900 | 000 |
| 06936415926700 | K212900 | 000 |
| 06936415926724 | K212900 | 000 |
| 06936415926755 | K212900 | 000 |
| 06936415926809 | K212900 | 000 |
| 06936415926830 | K212900 | 000 |
| 06936415925765 | K212900 | 000 |