510(k) K213363 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
CARESCAPE B450, E-musb
| Applicant | GE Healthcare Finland Oy, Helsinki, FI |
| Decision | Substantially Equivalent, Apr 13, 2022 |
| Received | Oct 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213363
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2025 | GE Healthcare Finland Oy Carescape B450, Model no. 5805686 - shipped with potentially affected batteries or affected batteries installed as a spare part
Monitor, Physiological, Patient (With
Arrhythmia Detection or Alarms
R Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.