510(k) K223531 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
| Applicant | GE Healthcare Finland Oy, Helsinki, FI |
| Decision | Substantially Equivalent, Apr 6, 2023 |
| Received | Nov 23, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223531
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2024 | GE Healthcare Finland Oy CARESCAPE Canvas 1000, Model Numbers:
a) 5865770;
b) 5865770-01040169;
c) 5865770-01054142;
d) 5865770-01054696;
e) 5865770-01054698;
f) 5865770-01054721;
g) 5865770-01054740;
h) 5865770-0105 Open, Classified |
MHX | None listed |
| Jun 21, 2024 | GE Healthcare Finland Oy CARESCAPE Canvas Smart Display, Model Numbers:
a) 5700023,
b) 5700023-02,
c) 5939590-102;
monitor, physiological, patient Open, Classified |
MHX | None listed |
| Sep 29, 2023 | GE Medical Systems China Co., Ltd. F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.