510(k) K193152 ยท KPS System, Tomography, Computed, Emission
Affinity
| Applicant | Hermes Medical Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, Feb 14, 2020 |
| Received | Nov 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193152
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.