K232285
- 510(k) number
- K232285
- Device name
- U-Lite PRO
- Applicant
- Sonoscanner Sarl FR
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-01-11
- Date received
- 2023-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232285.pdf
Official FDA record: K232285
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.