510(k) K130711 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
INFINITY CENTRALSTATION WITH INFINITY M300
| Applicant | Draeger Medical Systems, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Apr 11, 2013 |
| Received | Mar 15, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130711
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2022 | Draegar Medical Systems, Inc. Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices. Open, Classified |
MHX | None listed |
| Oct 9, 2019 | Draegar Medical Systems, Inc. Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301 Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.