510(k) K970970 ยท KPS System, Tomography, Computed, Emission
CARDIOMATCH
| Applicant | Focus Medical SA, Wellesley MA, US |
| Decision | Substantially Equivalent, Jun 13, 1997 |
| Received | Mar 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970970
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.