The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for M9/m9cv/m9t/m8 Elite/m10/m10cv/crius M10/m11/m11cv/crius M11/operus M11/m9 Premium Diagnostic Ultrasound System.
| Device ID | K210416 |
| 510k Number | K210416 |
| Device Name: | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium 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 | 2021-02-11 |
| Decision Date | 2021-06-10 |