510(k) K053648 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
PIONEER TC8080, COMPANION III
| Applicant | Viasys Neuro Care, Stoughton WI, US |
| Decision | Substantially Equivalent, Jan 24, 2006 |
| Received | Dec 30, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K053648
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.