510(k) K061379 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
INFINITY TELESMART TELEMETRY SYSTEM
| Applicant | Draeger Medical Systems, Inc., Danvers MA, US |
| Decision | Substantially Equivalent, Feb 16, 2007 |
| Received | May 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061379
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.