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 Diagnostic.
| Device ID | K173471 |
| 510k Number | K173471 |
| Device Name: | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
| Contact | Yang Zhaohui |
| Correspondent | Yang Zhaohui 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 | 2017-11-08 |
| Decision Date | 2018-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904099101 | K173471 | 000 |
| 06936415906221 | K173471 | 000 |
| 06944904095486 | K173471 | 000 |
| 06944904095820 | K173471 | 000 |
| 06944904095837 | K173471 | 000 |
| 06944904095844 | K173471 | 000 |
| 06944904097749 | K173471 | 000 |
| 06944904098487 | K173471 | 000 |
| 06944904099071 | K173471 | 000 |
| 06944904099088 | K173471 | 000 |
| 06944904099095 | K173471 | 000 |
| 06936415906214 | K173471 | 000 |