The following data is part of a premarket notification filed by Shenzhen Mindray Bio-meidcal Electronics Co., Ltd with the FDA for Resona R9,resona R9 Exp,resona R9 Pro,resona R9s, Nuewa R9,nuewa R9 Exp,nuewa R9 Pro,nuewa R9s,resona 7,resona 7cv,resona 7exp,resona 7s, Resona 7ob,resona 7pro,imagyn 7,resona Y Diagnostic Ultrasound System.
| Device ID | K202785 |
| 510k Number | K202785 |
| Device Name: | Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shenzhen Mindray Bio-Meidcal Electronics Co., LTD Keji 12th Road South, Hi-tech Industrial Park Shenzhen, CN 518057 |
| Contact | Ma Chao |
| Correspondent | Ma Chao 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 | 2020-09-22 |
| Decision Date | 2021-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06936415971083 | K202785 | 000 |
| 06936415970901 | K202785 | 000 |
| 06936415970918 | K202785 | 000 |
| 06936415970925 | K202785 | 000 |
| 06936415970932 | K202785 | 000 |
| 06936415970949 | K202785 | 000 |
| 06936415970956 | K202785 | 000 |
| 06936415970963 | K202785 | 000 |
| 06936415970970 | K202785 | 000 |
| 06936415970987 | K202785 | 000 |
| 06903053000031 | K202785 | 000 |