510(k) K201764 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Infinity Acute Care System (IACS) Monitoring Solution
| Applicant | Draeger Medical Systems, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Dec 9, 2021 |
| Received | Jun 29, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201764
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.