510(k) K191323 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Carescape B850
| Applicant | GE Healthcare Finland Oy, Helsinki, FI |
| Decision | Substantially Equivalent, Jan 29, 2020 |
| Received | May 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191323
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2024 | GE Healthcare Finland Oy CARESCAPE Canvas Smart Display, Model Numbers:
a) 5514418,
b) 5514418 / MAEP2,
c) 5514418-01059642,
d) 5514418-01080402,
e) 5514418-01081317,
f) 5514418-01086007,
g) 5514418-01086838,
h) 55 Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.