The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Z5/z50/z50t/z50s/z50 Pro Diagnostic Ultrasound System.
| Device ID | K200251 |
| 510k Number | K200251 |
| Device Name: | Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ShenZhen Mindray Bio-Medical Electronics Co., Ltd Mindray Building, Keji 12th Road South, Hi-Tech Industrial Park Shenzhen, CN 518057 |
| Contact | Shi Jufang |
| Correspondent | Shi Jufang SHENZHEN MINDRAY BIOMEDICAL ELECTRONICS CO., LTD. Mindray Building, 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 | 2020-02-03 |
| Decision Date | 2020-04-02 |