510(k) K180535 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Voluson P6 and Voluson P8
| Applicant | GE Healthcare, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Mar 29, 2018 |
| Received | Feb 28, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180535
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2019 | GE Healthcare, LLC Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.