510(k) K073462 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES
| Applicant | Ge Medical Systems Information Technologies, Needham MA, US |
| Decision | Substantially Equivalent, Jan 11, 2008 |
| Received | Dec 10, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073462
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2018 | GE Healthcare, LLC Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients. Open, Classified |
MHX | None listed |
| Feb 14, 2014 | GE Healthcare, LLC GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station. Terminated |
MHX | None listed |
| Jan 22, 2014 | GE Healthcare, LLC GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.
K073462: The Dash Terminated |
MHX | None listed |
| Aug 28, 2013 | GE Healthcare, LLC GE Healthcare, Dash 3000, Dash 4000 and Dash 5000.
Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. Terminated |
MHX | None listed |
| Feb 14, 2013 | GE Healthcare, LLC GE Healthcare, Dash Port 2 Docking Station.
Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, Terminated |
MHX | None listed |
| Feb 13, 2013 | GE Healthcare, LLC GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories. Terminated |
MHX | None listed |
| Dec 16, 2012 | GE Healthcare, LLC GE Healthcare, Dash 3000/4000/5000.
The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is t Terminated |
MHX | None listed |
| Aug 25, 2011 | GE Healthcare, LLC GE Healthcare, DASH 3000, 4000, 5000 Patient Monitors
The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use Terminated |
MHX | None listed |
| Nov 15, 2010 | GE Healthcare, LLC Power supply boards on Dash 3000, 4000 and 5000 Monitors.
GE Healthcare, 8200 West Tower Avenue, Milwaukee, WI 53223. Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.