510(k) K082656 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT
| Applicant | Fukuda Denshi USA, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Sep 30, 2008 |
| Received | Sep 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082656
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.