510(k) K092027 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
CARESCAPE MONITOR B850
| Applicant | Ge Medical Systems Information Technologies, Needham MA, US |
| Decision | Substantially Equivalent, Aug 28, 2009 |
| Received | Jul 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092027
| 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 |
| Feb 4, 2014 | GE Healthcare, LLC CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.
Product Usage: The CARESCAPE Monitor B850 is inte Terminated |
MHX | None listed |
| Jan 28, 2014 | GE Healthcare, LLC GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850.
The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within Terminated |
MHX | None listed |
| Sep 16, 2013 | GE Healthcare, LLC GE Healthcare, CARESCAPE Monitor B850.
Intended for use in multiple areas within a professional healthcare facility. Terminated |
MHX | None listed |
| Jun 21, 2013 | GE Healthcare, LLC CARESCAPE Monitor B850
Product Usage:
The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on Terminated |
MHX | None listed |
| Apr 8, 2011 | GE Healthcare, LLC GE
The CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a high acuity, multi-parameter patient monitoring system. A typical configuration would be a CARESCAPE M Terminated |
MHX | None listed |
| Aug 25, 2010 | GE Healthcare, LLC CARESCAPE MONITOR B850
Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.