510(k) K181985 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Voluson E6, Voluson E8, Voluson E10
| Applicant | GE Healthcare, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Nov 15, 2018 |
| Received | Jul 25, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181985
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2019 | GE Healthcare, LLC Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.