510(k) K050815 ยท KPS System, Tomography, Computed, Emission
XACT.CARDIAC & XPRESS.CARDIAC
| Applicant | Ultraspect , Ltd., Hafia, IL |
| Decision | Substantially Equivalent, Apr 26, 2005 |
| Received | Mar 31, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050815
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.