510(k) K191249 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
CARESCAPE B450
| Applicant | GE Healthcare Finland Oy, Helsinki, FI |
| Decision | Substantially Equivalent, Jan 24, 2020 |
| Received | May 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191249
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.