The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for M6/m6t/m6 Exp/m6s/m6 Pro/m5 Exp/m55/m58 Diagnostic Ultrasound System.
| Device ID | K171579 |
| 510k Number | K171579 |
| Device Name: | M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 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, 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 | 2017-05-31 |
| Decision Date | 2017-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904098357 | K171579 | 000 |
| 06944904098340 | K171579 | 000 |
| 06944904098333 | K171579 | 000 |
| 06944904098326 | K171579 | 000 |
| 06944904098319 | K171579 | 000 |
| 06944904098302 | K171579 | 000 |
| 06944904098296 | K171579 | 000 |
| 06944904092485 | K171579 | 000 |
| 06944904095509 | K171579 | 000 |