510(k) K060833 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
12SL ECG ANALYSIS PROGRAM
| Applicant | Ge Medical Systems Information Technologies, Milwaukee WI, US |
| Decision | Substantially Equivalent, Aug 1, 2006 |
| Received | Mar 27, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060833
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.