510(k) K211216 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Vivid S60N / Vivid S70N
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Jun 9, 2021 |
| Received | Apr 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211216
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2023 | GE Vingmed Ultrasound As GE Healthcare Vivid S60N, ultrasound device Open, Classified |
IYN | None listed |
| Jul 10, 2023 | GE Vingmed Ultrasound As GE Healthcare Vivid S70N, ultrasound device Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.