510(k) K202160 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System
| Applicant | FUJIFILM Sonosite, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Sep 1, 2020 |
| Received | Aug 3, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202160
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.