510(k) K012887 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SA6000II DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Medison America, Inc., San Leandro CA, US |
| Decision | Substantially Equivalent, Sep 12, 2001 |
| Received | Aug 28, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012887
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.