K233394
- 510(k) number
- K233394
- Device name
- Gem Flow Now (GEM2770-FN)
- Applicant
- Synovis Micro Companies Alliance AL · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2024-01-28
- Date received
- 2023-10-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K233394.pdf
Official FDA record: K233394
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.