The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co.,ltd with the FDA for Resona 7/resona 7cv/resona 7exp/resona 7s/resona 7ob Diagnostic Ultrasound System.
| Device ID | K162267 |
| 510k Number | K162267 |
| Device Name: | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD MINDRAY BUILDING, KEJI 12TH RD S, 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 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-11 |
| Decision Date | 2016-09-06 |
| Summary: | summary |