K231677
- 510(k) number
- K231677
- Device name
- EdgeFlow UH10
- Applicant
- Edgecare, Inc. KR
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2024-03-06
- Date received
- 2023-06-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K231677.pdf
Official FDA record: K231677
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.