K232704
- 510(k) number
- K232704
- Device name
- Clarius Ultrasound Scanner
- Applicant
- Clarius Mobile Health Corp. CA
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2023-10-05
- Date received
- 2023-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K232704.pdf
Official FDA record: K232704
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.