510(k) K081201 ยท KPS System, Tomography, Computed, Emission
WBR XPRESS3.CARDIAC
| Applicant | Ultraspect , Ltd., Haifa, IL |
| Decision | Substantially Equivalent, May 28, 2008 |
| Received | Apr 28, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081201
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.