The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for M9/m9cv/m9t Diagnostic Ultrasound System.
| Device ID | K152543 |
| 510k Number | K152543 |
| Device Name: | M9/M9CV/M9T 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 HI-TECH INDUSTRIAL PARK, NANSHAN Shenzhen, CN 518057 |
| Contact | Wu Zicui |
| Correspondent | Wu Zicui Shenzhen Mindray Bio-Medical Electronics Co., Ltd 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 | 2015-09-04 |
| Decision Date | 2015-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904090146 | K152543 | 000 |
| 06944904087269 | K152543 | 000 |
| 06944904063294 | K152543 | 000 |
| 06944904063171 | K152543 | 000 |
| 06944904051475 | K152543 | 000 |
| 06944904049052 | K152543 | 000 |
| 06944904049045 | K152543 | 000 |
| 06944904049038 | K152543 | 000 |
| 06944904049007 | K152543 | 000 |
| 06944904048994 | K152543 | 000 |
| 06944904048970 | K152543 | 000 |
| 06944904087399 | K152543 | 000 |
| 06944904087405 | K152543 | 000 |
| 06944904088044 | K152543 | 000 |
| 06944904090139 | K152543 | 000 |
| 06944904089621 | K152543 | 000 |
| 06944904088372 | K152543 | 000 |
| 06944904088341 | K152543 | 000 |
| 06944904088310 | K152543 | 000 |
| 06944904088242 | K152543 | 000 |
| 06944904088235 | K152543 | 000 |
| 06944904088228 | K152543 | 000 |
| 06944904088211 | K152543 | 000 |
| 06944904088051 | K152543 | 000 |
| 06944904048567 | K152543 | 000 |