510(k) K010509 ยท KPS System, Tomography, Computed, Emission
CEDARS-SINAI BPGS AND MOCO
| Applicant | Smv America, Twinsburg OH, US |
| Decision | Substantially Equivalent, Apr 27, 2001 |
| Received | Feb 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010509
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.