510(k) K131045 ยท DQK Computer, Diagnostic, Programmable
ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
| Applicant | Cardiac Designs, LLC, Monroe CT, US |
| Decision | Substantially Equivalent, May 29, 2013 |
| Received | Apr 15, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131045
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.