The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for M5 Diagnostic Ultrasound System.
| Device ID | K102991 |
| 510k Number | K102991 |
| Device Name: | M5 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD KEJI 12TH RD SOUTH HI-TECH INDUSTRIAL PARK Nanshan,shenzhen, Guangdong, CN 518057 |
| Contact | Zhai Pei |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-10-07 |
| Decision Date | 2010-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904001647 | K102991 | 000 |
| 06944904033969 | K102991 | 000 |
| 06944904054117 | K102991 | 000 |
| 06944904063133 | K102991 | 000 |
| 06944904085586 | K102991 | 000 |
| 06944904086545 | K102991 | 000 |
| 06944904086552 | K102991 | 000 |
| 06944904086941 | K102991 | 000 |
| 06944904087122 | K102991 | 000 |
| 06944904023991 | K102991 | 000 |
| 06944904023694 | K102991 | 000 |
| 06944904001654 | K102991 | 000 |
| 06944904001685 | K102991 | 000 |
| 06944904001692 | K102991 | 000 |
| 06944904001807 | K102991 | 000 |
| 06944904018553 | K102991 | 000 |
| 06944904018560 | K102991 | 000 |
| 06944904018577 | K102991 | 000 |
| 06944904023564 | K102991 | 000 |
| 06944904087184 | K102991 | 000 |
| 06944904088693 | K102991 | 000 |
| 06944904088778 | K102991 | 000 |
| 06944904089515 | K102991 | 000 |
| 06944904089706 | K102991 | 000 |
| 06944904089744 | K102991 | 000 |
| 06944904089829 | K102991 | 000 |
| 06944904089836 | K102991 | 000 |
| 06944904089843 | K102991 | 000 |
| 06944904089942 | K102991 | 000 |
| 06944904089959 | K102991 | 000 |
| 06944904089324 | K102991 | 000 |
| 06944904089270 | K102991 | 000 |
| 06944904088808 | K102991 | 000 |
| 06944904088839 | K102991 | 000 |
| 06944904088877 | K102991 | 000 |
| 06944904088983 | K102991 | 000 |
| 06944904089010 | K102991 | 000 |
| 06944904089119 | K102991 | 000 |
| 06944904089195 | K102991 | 000 |
| 06944904089218 | K102991 | 000 |
| 06944904089966 | K102991 | 000 |