510(k) K102239 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
CARESCAPE MONITOR B650
| Applicant | GE Healthcare Finland Oy, Helsinki, FI |
| Decision | Substantially Equivalent, Oct 18, 2010 |
| Received | Aug 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102239
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 25, 2018 | GE Healthcare Finland Oy GE Healthcare CARESCAPE Monitor B650 Open, Classified |
DQK | None listed |
| May 12, 2015 | GE Healthcare GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50). Terminated |
MHX | None listed |
| Jul 24, 2014 | GE Healthcare, LLC GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. 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 |
| 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 19, 2013 | GE Healthcare, LLC GE Healthcare, CARESCAPE Monitor B650.
The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare Terminated |
MHX | None listed |
| Feb 14, 2013 | GE Healthcare, LLC GE Healthcare, CARESCAPE Monitor B650.
The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare Terminated |
MHX | None listed |
| Apr 8, 2011 | GE Healthcare, LLC GE Healthcare, CARESCAPE Monitor B650
The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare f Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.