The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dc-t6 Diagnostic Ultrasound System.
| Device ID | K120699 |
| 510k Number | K120699 |
| Device Name: | DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH RD SOUTH, HI-TECH INDUSTRIAL PARK Nanshan,shenzhen, P.r. China, CN 518057 |
| Contact | Wu Zicui |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2012-03-07 |
| Decision Date | 2012-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904089782 | K120699 | 000 |
| 06944904089676 | K120699 | 000 |
| 06944904087146 | K120699 | 000 |
| 06944904086538 | K120699 | 000 |
| 06944904033334 | K120699 | 000 |
| 06944904033327 | K120699 | 000 |
| 06944904033310 | K120699 | 000 |
| 06944904027944 | K120699 | 000 |