510(k) K140933 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
ALIVECOR HEART MONITOR
| Applicant | AliveCor, Inc., San Francisco CA, US |
| Decision | Substantially Equivalent, Aug 15, 2014 |
| Received | Apr 11, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140933
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2015 | Alivecor SFO Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and Terminated |
DXH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.