510(k) K131414 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
CARESCAPE MONITOR B850
| Applicant | GE Healthcare Finland Oy, Helsinki, FI |
| Decision | Substantially Equivalent, Aug 28, 2013 |
| Received | May 16, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131414
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2015 | GE Healthcare GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). Terminated |
MHX | None listed |
| Jul 21, 2014 | GE Healthcare, LLC GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. Terminated |
MHX | None listed |
| Mar 11, 2014 | GE Healthcare, LLC GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850.
K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.