The following data is part of a premarket notification filed by Shenzhen Mindray Bio-meidcal Electronics Co., Ltd with the FDA for Dc-30/dc-32/dc-28/dc-26/dc-25 Diagnostic Ultrasound System.
| Device ID | K173369 |
| 510k Number | K173369 |
| Device Name: | DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
| Contact | Jean Lei |
| Correspondent | Jean Lei Shenzhen Mindray Bio-Meidcal 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 | 2017-10-27 |
| Decision Date | 2017-12-13 |
| Summary: | summary |