K231989
- 510(k) number
- K231989
- Device name
- LOGIQ E10s, LOGIQ Fortis
- Applicant
- Ge Medical Systems Ultrasound and Primary Care Diagnostic, WI · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2023-11-07
- Date received
- 2023-07-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231989.pdf
Official FDA record: K231989
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.