K231659
- 510(k) number
- K231659
- Device name
- MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus)
- Applicant
- Medisono FL · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-02-15
- Date received
- 2023-06-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231659.pdf
Official FDA record: K231659
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.