510(k) K053435 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE VOLUSON I
| Applicant | General Electric Co., Milwaukee WI, US |
| Decision | Substantially Equivalent, Dec 16, 2005 |
| Received | Dec 9, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053435
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.