The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Te7 Diagnostic Ultrasound, Te5 Diagnostic Ultrasound System.
| Device ID | K161525 |
| 510k Number | K161525 |
| Device Name: | TE7 Diagnostic Ultrasound, 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 | Wu Zicui |
| Correspondent | Wu Zicui 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 | 2016-06-02 |
| Decision Date | 2016-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904092980 | K161525 | 000 |
| 06944904092638 | K161525 | 000 |
| 06944904091860 | K161525 | 000 |
| 06944904090160 | K161525 | 000 |
| 06944904089607 | K161525 | 000 |
| 06944904088655 | K161525 | 000 |
| 06944904088594 | K161525 | 000 |
| 06944904088150 | K161525 | 000 |
| 06944904054667 | K161525 | 000 |
| 06944904051871 | K161525 | 000 |
| 06944904051833 | K161525 | 000 |
| 06944904092867 | K161525 | 000 |
| 06944904092874 | K161525 | 000 |
| 06944904092973 | K161525 | 000 |
| 06944904092966 | K161525 | 000 |
| 06944904092959 | K161525 | 000 |
| 06944904092942 | K161525 | 000 |
| 06944904092935 | K161525 | 000 |
| 06944904092928 | K161525 | 000 |
| 06944904092911 | K161525 | 000 |
| 06944904092904 | K161525 | 000 |
| 06944904092898 | K161525 | 000 |
| 06944904092881 | K161525 | 000 |
| 06944904051826 | K161525 | 000 |