The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Resona 6/resona 6t/resona 6exp/resona 6elite Diagnostic Ultrasound System/resona 6s/resona 6pro/resona 6ob Diagnostic Ultrasound System /resona 5/resona 5t/resona 5exp/resona 5elite Diagnostic Ultrasound System.
| Device ID | K172860 |
| 510k Number | K172860 |
| Device Name: | Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ShenZhen Mindray Bio-Medical Electronics Co., Ltd Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
| Contact | Ma Chao |
| Correspondent | Ma Chao ShenZhen Mindray Bio-Medical Electronics Co., Ltd Mindray Building, Keji 12th Road South High-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 | 2017-09-20 |
| Decision Date | 2018-01-02 |
| Summary: | summary |