The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for M7/m7t Diagnostic Ultrasound System.
| Device ID | K121010 |
| 510k Number | K121010 |
| Device Name: | M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BLDG. 9-13 BAIWANGXIN HIGH-TEC INDUSTRIAL PARK Shenzhen, CN 518108 |
| Contact | Yang Zhaohui |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2012-04-03 |
| Decision Date | 2012-04-19 |
| Summary: | summary |