The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co.,ltd with the FDA for Dc-40/dc-35/dc-45/dc-40s/dc-40 Pro Diagnostic Ultrasound System.
| Device ID | K162845 |
| 510k Number | K162845 |
| Device Name: | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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 | Zhai Pei |
| Correspondent | Zhai Pei SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD MINDRAY BUILDING, KEJI 12TH ROAD SOUTH, 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 | No |
| Combination Product | No |
| Date Received | 2016-10-11 |
| Decision Date | 2016-12-15 |
| Summary: | summary |