510(k) K240115 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Apr 22, 2024 |
| Received | Jan 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240115
No recall in the FDA data names this 510(k).
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