Search Results
Found 1 results
510(k) Data Aggregation
K Number
K973640Device Name
TS2000 MEDICAL DEVICE MONITOR
Manufacturer
Date Cleared
1998-03-12
(169 days)
Product Code
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
TRINCORE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TS2000 Medical Device Monitor is intended to be used as a central monitoring station on those patients being monitored by pulse oximeter and infusion pump medical devices. It is used to provide a secondary display of the data from the medical devices to the centrally located TS2000 System display. It is intended for use by healthcare professionals trained in the use of the equipment only.
The TS2000 is intended for use by healthcare professionals thoroughly familiar with the features and operations of the TS2000. The TS2000 is intended to supplement and not to replace any part of the current device monitoring procedures.
The TS2000 is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician's care
Device Description
The TS2000 Medical Device Monitor is a PC based Central Monitoring Station that takes the information from different medical devices and redisplays them on a single monitor in a central location. It allows the remote monitoring of multiple medical devices simultaneously at the central station. The TS2000 provides secondary annunciation of the alarms from the medical devices at the central station as well.
Ask a Question
Ask a specific question about this device
Page 1 of 1