K250024
- 510(k) number
- K250024
- Device name
- TE Air Diagnostic Ultrasound System
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. CN
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2025-05-30
- Date received
- 2025-01-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K250024.pdf
Official FDA record: K250024
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.