510(k) K043439 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL
| Applicant | Draeger Medical Systems, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Feb 18, 2005 |
| Received | Dec 14, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043439
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.