510(k) K192277 ยท KPS System, Tomography, Computed, Emission
CardIQ Flow
| Applicant | GE Medical Systems SCS, Buc, FR |
| Decision | Substantially Equivalent, Feb 14, 2020 |
| Received | Aug 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192277
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.