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 Diagnostic Ultrasound System, Me7/ Anesus Me7/ Anesus Me7t Diagnostic Ultrasound System, Mx8/ Mx8t/ Vaus8/ Me8 Diagnostic Ultrasound System.
| Device ID | K200001 |
| 510k Number | K200001 |
| Device Name: | MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, 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 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 | 2020-01-02 |
| Decision Date | 2020-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06936415925925 | K200001 | 000 |
| 06936415980894 | K200001 | 000 |
| 06936415982539 | K200001 | 000 |
| 06936415903008 | K200001 | 000 |
| 06936415903022 | K200001 | 000 |
| 06936415925864 | K200001 | 000 |
| 06936415925888 | K200001 | 000 |
| 06936415925895 | K200001 | 000 |
| 06936415925918 | K200001 | 000 |
| 06936415974596 | K200001 | 000 |