510(k) K043549 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
INFINITY GATEWAY SUITE, VF4
| Applicant | Draeger Medical Systems, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Jan 21, 2005 |
| Received | Dec 23, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043549
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.