The following data is part of a premarket notification filed by Shenzhen Mindray Bio-meidcal Electronics Co., Ltd with the FDA for Resona 7/resona 7cv/resona 7exp/resona 7s/resona 7ob Diagnostic Ultrasound System.
| Device ID | K171233 |
| 510k Number | K171233 |
| 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-Meidcal 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-Meidcal 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 | 2017-04-27 |
| Decision Date | 2017-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904098036 | K171233 | 000 |
| 06944904092799 | K171233 | 000 |
| 06944904092782 | K171233 | 000 |
| 06944904092775 | K171233 | 000 |
| 06944904092768 | K171233 | 000 |
| 06944904091884 | K171233 | 000 |
| 06944904088617 | K171233 | 000 |
| 06944904091976 | K171233 | 000 |
| 06936415912307 | K171233 | 000 |
| 06944904092805 | K171233 | 000 |
| 06944904092812 | K171233 | 000 |
| 06944904097978 | K171233 | 000 |
| 06944904097961 | K171233 | 000 |
| 06944904093093 | K171233 | 000 |
| 06944904093086 | K171233 | 000 |
| 06944904093079 | K171233 | 000 |
| 06944904092843 | K171233 | 000 |
| 06944904092836 | K171233 | 000 |
| 06944904092829 | K171233 | 000 |
| 06936415904036 | K171233 | 000 |