510(k) K151860 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Infinity CentralStation Wide
| Applicant | Draeger Medical Systems, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Sep 2, 2015 |
| Received | Jul 8, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151860
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2025 | Draeger Medical Systems, Inc. Infinity Central Station. Model Number: MS26800
The Infinity CentralStation (ICS) is intended for centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical Open, Classified |
MHX | None listed |
| Apr 27, 2023 | Draeger Medical Systems, Inc. Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.