510(k) K200859 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Infinity M300
| Applicant | Draeger Medical Systems, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Aug 28, 2020 |
| Received | Apr 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200859
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2023 | Draeger Medical Systems, Inc. Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity pat Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.