510(k) K170445 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
LOGIQ S8
| Applicant | GE Healthcare, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Apr 11, 2017 |
| Received | Feb 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170445
| 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.