510(k) K033492 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
| Applicant | Ge Medical Systems Information Technologies, Milwaukee WI, US |
| Decision | Substantially Equivalent, Nov 24, 2003 |
| Received | Nov 4, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033492
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.