510(k) K031320 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
EK-PRO ARRHYTHMIA DETECTION ALGORITHM
| Applicant | Ge Medical Systems Information Technologies, Milwaukee WI, US |
| Decision | Substantially Equivalent, May 6, 2003 |
| Received | Apr 25, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031320
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.