510(k) K002209 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE MARQUETTE ECG ANALYSIS PROGRAM
| Applicant | General Electric Medical Systems Information Techn, Milwaukee WI, US |
| Decision | Substantially Equivalent, Aug 18, 2000 |
| Received | Jul 21, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002209
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.