510(k) K203137 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Venue Fit
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Dec 29, 2020 |
| Received | Oct 20, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203137
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 11, 2025 | GE Medical Systems, LLC Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for Chin Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.