The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd. with the FDA for Z6/z60/z60t/z60s/z60 Pro/dp-60 Diagnostic Ultrasound System.
| Device ID | K200411 |
| 510k Number | K200411 |
| Device Name: | Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 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 | 2020-02-19 |
| Decision Date | 2020-04-08 |