510(k) K163394 ยท KPS System, Tomography, Computed, Emission
Hybrid3D
| Applicant | Hermes Medical Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, May 22, 2017 |
| Received | Dec 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163394
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.