The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Te7/te5 Diagnostic Ultrasound System.
| Device ID | K180912 |
| 510k Number | K180912 |
| Device Name: | TE7/TE5 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 | 2018-04-06 |
| Decision Date | 2018-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904099613 | K180912 | 000 |
| 06944904095479 | K180912 | 000 |
| 06936415903060 | K180912 | 000 |
| 06936415903053 | K180912 | 000 |
| 06936415911706 | K180912 | 000 |
| 06944904092652 | K180912 | 000 |
| 06936415978907 | K180912 | 000 |
| 06936415978891 | K180912 | 000 |