510(k) K091594 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
HEART-EXERCISE
| Applicant | Ge Medical Systems Information Technologies GmbH, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Jul 29, 2009 |
| Received | Jun 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091594
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.