Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class II · Cleared Feb 7, 2023
| K-number | K222928 |
| Device name | Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| Product code | IYN |
| Device class | Class II |
| Decision date | Feb 7, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 892.1550 |
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