510(k) K203088 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Infinity Acute Care System (IACS) Monitoring System
| Applicant | Draeger Medical Systems, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Feb 1, 2022 |
| Received | Oct 13, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203088
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2024 | Draeger Medical Systems, Inc. Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23 Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.