510(k) K042258 ยท KPS System, Tomography, Computed, Emission
BP-SPECT V1.O
| Applicant | Syntermed, Inc., Anaheim CA, US |
| Decision | Substantially Equivalent, Oct 4, 2004 |
| Received | Aug 20, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042258
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.