510(k) K133753 ยท QYX Outpatient Cardiac Telemetry
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR
| Applicant | Infobionic, Inc., Lowell MA, US |
| Decision | Substantially Equivalent, Sep 19, 2014 |
| Received | Dec 9, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133753
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.