510(k) K160064 ยท QYX Outpatient Cardiac Telemetry
MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
| Applicant | Infobionic, Inc., Lowell MA, US |
| Decision | Substantially Equivalent, Mar 11, 2016 |
| Received | Jan 13, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K160064
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.