510(k) K111159 ยท DPS Electrocardiograph
HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME
| Applicant | Cardiocomm Solutions, Inc., Appollo Beach FL, US |
| Decision | Substantially Equivalent, Dec 22, 2011 |
| Received | Apr 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111159
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.