The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd. with the FDA for M9 Diagnostic Ultrasound System, M9t Diagnostic Ultrasound System, M9cv Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System.
| Device ID | K171034 |
| 510k Number | K171034 |
| Device Name: | M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite 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, Nanshan Shenzhen, CN |
| Contact | Ma Chao |
| Correspondent | Ma Chao Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, CN |
| 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 | 2017-04-06 |
| Decision Date | 2017-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904095653 | K171034 | 000 |
| 06944904097060 | K171034 | 000 |
| 06944904097053 | K171034 | 000 |
| 06944904097046 | K171034 | 000 |
| 06944904097039 | K171034 | 000 |
| 06944904097022 | K171034 | 000 |
| 06944904097015 | K171034 | 000 |
| 06944904097008 | K171034 | 000 |
| 06944904096995 | K171034 | 000 |
| 06944904096988 | K171034 | 000 |
| 06944904097077 | K171034 | 000 |
| 06944904097084 | K171034 | 000 |
| 06944904095547 | K171034 | 000 |
| 06944904092515 | K171034 | 000 |
| 06944904088471 | K171034 | 000 |
| 06936415904029 | K171034 | 000 |
| 06944904096971 | K171034 | 000 |
| 06944904097947 | K171034 | 000 |
| 06944904097114 | K171034 | 000 |
| 06944904097107 | K171034 | 000 |
| 06944904097091 | K171034 | 000 |
| 06936415906191 | K171034 | 000 |