The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dc-n3/dc-ns3 Diagnostic Ultrasound System.
| Device ID | K123503 |
| 510k Number | K123503 |
| Device Name: | DC-N3/DC-NS3 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 | Bai Yanhong |
| 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 | 2012-11-13 |
| Decision Date | 2012-12-13 |
| Summary: | summary |