510(k) K132533 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
CARESCAPE MONITOR B450
| Applicant | GE Healthcare Finland Oy, Helsinki, FI |
| Decision | Substantially Equivalent, Dec 4, 2013 |
| Received | Aug 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132533
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2018 | GE Healthcare Finland Oy GE Healthcare CARESCAPE Monitor B450
Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for u Open, Classified |
DQK | None listed |
| Sep 4, 2018 | GE Healthcare Finland Oy GE Healthcare CARESCAPE Monitor B850
Product Usage:
Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monito Open, Classified |
DQK | None listed |
| May 12, 2015 | GE Healthcare GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.