510(k) K213264 ยท DQK Computer, Diagnostic, Programmable
CARTO 3 EP Navigation System Version 7.2
| Applicant | Biosense Webster, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Oct 29, 2021 |
| Received | Sep 30, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213264
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.