510(k) K162440 ยท DQK Computer, Diagnostic, Programmable
CardioInsight Cardiac Mapping System
| Applicant | Cardioinsight Technologies, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Nov 4, 2016 |
| Received | Aug 31, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162440
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.