510(k) K033957 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL
| Applicant | Draeger Medical Systems, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, May 14, 2004 |
| Received | Dec 22, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033957
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.