510(k) K231576 ยท KPS System, Tomography, Computed, Emission
cNeuro cPET
| Applicant | Combinostics OY, Tampere, FI |
| Decision | Substantially Equivalent, Sep 14, 2023 |
| Received | May 31, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231576
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.