510(k) K171719 ยท KPS System, Tomography, Computed, Emission
Hybrid3D
| Applicant | Hermes Medical Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, Nov 21, 2017 |
| Received | Jun 9, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171719
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.