510(k) K141963 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
12SL ECG ANALYSIS PROGRAM
| Applicant | Ge Medical Systems Information Technologies, Inc., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Feb 5, 2015 |
| Received | Jul 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141963
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.