510(k) K221904 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
EK12 V2 Algorithm
| Applicant | Ge Medical Systems Information Technologies, Inc., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Dec 20, 2022 |
| Received | Jun 30, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221904
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.