510(k) K200484 · DQK Computer, Diagnostic, Programmable
CARTO® 3 EP Navigation System with Signal Processing Unit
| Applicant | Biosense Webster, Inc., Irvin CA, US |
| Decision | Substantially Equivalent, Nov 25, 2020 |
| Received | Feb 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200484
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.