510(k) K153626 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SonoSite Edge II Ultrasound System
| Applicant | FUJIFILM Sonosite, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Jan 20, 2016 |
| Received | Dec 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153626
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.