The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Dc-n2/dc-n2s Diagnostic Ultrasound System.
| Device ID | K132779 |
| 510k Number | K132779 |
| Device Name: | DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BLDG. KEJI 12TH RD S. 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 | Yes |
| Combination Product | No |
| Date Received | 2013-09-05 |
| Decision Date | 2013-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904089669 | K132779 | 000 |
| 06944904086965 | K132779 | 000 |
| 06944904042053 | K132779 | 000 |