510(k) K031760 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
VIEWPOINT TELEMETRY SYSTEM
| Applicant | Datascope Corp., Mahwh NJ, US |
| Decision | Substantially Equivalent, Oct 10, 2003 |
| Received | Jun 6, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K031760
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2014 | Mindray DS USA, Inc. dba Mindray North America Panaroma Central Station
Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for da Terminated |
MHX | None listed |
| May 27, 2009 | Mindray DS USA, Inc., dba Datascope Patient Monitoring Panorama Patient Monitoring Network with ambulatory telepacks, and software version 8.5.5, 8.5.6, 8.6.1 or 8.7.
Datascope Patient Monitoring
Intended for use in a fixed location, in the healthcare fa Terminated |
MHX | None listed |
| Jan 24, 2006 | Datascope Corp Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor. Terminated |
MHX | None listed |
| Sep 21, 2005 | Datascope Corp Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor. Terminated |
DRT | None listed |
| Aug 6, 2005 | Datascope Corp Panorama Patient Monitoring Network. Cardiac Arrhythmia Monitor. Terminated |
DRT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.