510(k) K211964 ยท KPS System, Tomography, Computed, Emission
SubtlePET
| Applicant | Subtle Medical, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, Sep 28, 2021 |
| Received | Jun 24, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211964
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.