510(k) K223733 · DQK Computer, Diagnostic, Programmable
CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4
| Applicant | Biosense Webster, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 16, 2023 |
| Received | Dec 13, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223733
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.