510(k) K103649 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
VOLUSON S6, VOLUSON S8
| Applicant | GE Healthcare, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Mar 9, 2011 |
| Received | Dec 15, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103649
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.