K240406
- 510(k) number
- K240406
- Device name
- Sonio Detect
- Applicant
- Sonio FR
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-04-26
- Date received
- 2024-02-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K240406.pdf
Official FDA record: K240406
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.