510(k) K122387 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
VOLUSON P6, VOLUSON P8
| Applicant | GE Healthcare, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Sep 11, 2012 |
| Received | Aug 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122387
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.