510(k) K123646 ยท KPS System, Tomography, Computed, Emission
EMORY CARDIAC TOOLBOX 4.0
| Applicant | Syntermed, Inc., Anaheim CA, US |
| Decision | Substantially Equivalent, Feb 22, 2013 |
| Received | Nov 27, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123646
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.