510(k) K231207 · DQK Computer, Diagnostic, Programmable
CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
| Applicant | Biosense Webster, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 7, 2023 |
| Received | Apr 27, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231207
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.