K231685
- 510(k) number
- K231685
- 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
- 2023-10-26
- Date received
- 2023-06-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231685.pdf
Official FDA record: K231685
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.