The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for M7/m7t Diagnostic Ultrasound System.
| Device ID | K131690 |
| 510k Number | K131690 |
| Device Name: | M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH ROAD SOUTH HI-TECH INDUSTRIAL PARK, NANSHAN Shenzhen, Guangdong, 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, Guangdong, CN 518057 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-10 |
| Decision Date | 2013-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904089980 | K131690 | 000 |
| 06944904028781 | K131690 | 000 |
| 06944904033976 | K131690 | 000 |
| 06944904033983 | K131690 | 000 |
| 06944904049793 | K131690 | 000 |
| 06944904086569 | K131690 | 000 |
| 06944904087047 | K131690 | 000 |
| 06944904087078 | K131690 | 000 |
| 06944904087207 | K131690 | 000 |
| 06944904087245 | K131690 | 000 |
| 06944904087283 | K131690 | 000 |
| 06944904089362 | K131690 | 000 |
| 06944904089546 | K131690 | 000 |
| 06944904089751 | K131690 | 000 |
| 06944904089768 | K131690 | 000 |
| 06944904089850 | K131690 | 000 |
| 06944904001678 | K131690 | 000 |