K230066
- 510(k) number
- K230066
- Device name
- Carnation series Diagnostic Ultrasound System
- Applicant
- Shenzhen Wisonic Medical Technology Co. , Ltd. CN
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2023-09-15
- Date received
- 2023-01-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K230066.pdf
Official FDA record: K230066
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.