510(k) K202882 ยท KPS System, Tomography, Computed, Emission
Affinity
| Applicant | Hermes Medical Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, Dec 23, 2020 |
| Received | Sep 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202882
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.