510(k) K260579 · MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Infinity® Acute Care System (IACS) VG8.1
| Applicant | Draeger Medical Systems, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Aug 20, 2026 |
| Received | Feb 20, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260579
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.