K231354
- 510(k) number
- K231354
- Device name
- Pocket Ultrasound System (C10)
- Applicant
- Beijing Konted Medical Technology Co.,Ltd CN
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2023-12-20
- Date received
- 2023-05-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K231354.pdf
Official FDA record: K231354
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.