The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for M7/m7t/m7 Premium/m7 Expert/m7 Super Diagnostic Ultrasound.
| Device ID | K172970 |
| 510k Number | K172970 |
| Device Name: | M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ShenZhen Mindray Bio-Medical Electronics Co., Ltd Mindray Building, Keji 12th Road South High-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 High-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 | 2017-09-26 |
| Decision Date | 2017-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904098715 | K172970 | 000 |
| 06944904097084 | K172970 | 000 |
| 06944904097091 | K172970 | 000 |
| 06944904097107 | K172970 | 000 |
| 06944904097114 | K172970 | 000 |
| 06944904097947 | K172970 | 000 |
| 06944904098173 | K172970 | 000 |
| 06944904098272 | K172970 | 000 |
| 06944904098289 | K172970 | 000 |
| 06944904097077 | K172970 | 000 |
| 06944904097060 | K172970 | 000 |
| 06944904096988 | K172970 | 000 |
| 06944904096995 | K172970 | 000 |
| 06944904097008 | K172970 | 000 |
| 06944904097015 | K172970 | 000 |
| 06944904097022 | K172970 | 000 |
| 06944904097039 | K172970 | 000 |
| 06944904097046 | K172970 | 000 |
| 06944904097053 | K172970 | 000 |
| 06944904098517 | K172970 | 000 |
| 06944904098524 | K172970 | 000 |
| 06944904098630 | K172970 | 000 |
| 06944904098647 | K172970 | 000 |
| 06944904098654 | K172970 | 000 |
| 06944904098661 | K172970 | 000 |
| 06944904098678 | K172970 | 000 |
| 06944904098685 | K172970 | 000 |
| 06944904098692 | K172970 | 000 |
| 06944904098708 | K172970 | 000 |
| 06944904098623 | K172970 | 000 |
| 06944904098616 | K172970 | 000 |
| 06944904098531 | K172970 | 000 |
| 06944904098548 | K172970 | 000 |
| 06944904098555 | K172970 | 000 |
| 06944904098562 | K172970 | 000 |
| 06944904098579 | K172970 | 000 |
| 06944904098586 | K172970 | 000 |
| 06944904098593 | K172970 | 000 |
| 06944904098609 | K172970 | 000 |
| 06936415926250 | K172970 | 000 |