The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dc-80/dc-80 Pro/dc-80 Exp/dc-80s/dc-85/dc-86/dc-86s/dc-89/dc-tv/dc-tq Diagnostic Ultrasound System.
| Device ID | K192152 |
| 510k Number | K192152 |
| Device Name: | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ 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 | Zhang Wei |
| Correspondent | Zhang Wei 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 |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-09 |
| Decision Date | 2019-12-13 |