510(k) K001268 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS
| Applicant | General Electric Medical Systems Information Techn, Milwaukee WI, US |
| Decision | Substantially Equivalent, Jul 17, 2000 |
| Received | Apr 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001268
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.