Search Results
Found 1 results
510(k) Data Aggregation
K Number
K980688Device Name
INTEGRITI PATIENT MONITOR
Manufacturer
ALLIANCE INSTRUMENTS
Date Cleared
1999-03-16
(386 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Integriti Patient Monitor is intended for use on all adult and pediatric patients that require monitoring and collection of vital signs data, with alarm capability when vital signs exceed preset values. The information that is intended to be collected is from the ECG, SpO2, noninvasive and invasive blood pressures and temperature. The Integriti Patient Monitor is intended for use in all departments and locations of the hospital where such monitoring may take place, except in the proximity of magnetic resonance imaging. The Integriti Patient Monitor is also intended for use for patient vital signs monitoring during patient transport in the hospital environment. The Integriti Patient Monitor is intended for use by licensed practitioners. When there is no standard electrical power source, the Integriti Patient Monitor is intended for use using a 12 to 28 volt external power source. The Integriti Patient Monitor is also intended for use with patient information systems, acting as a source of vital signs information and as a terminal for accessing and entering information into the information system.
Device Description
Not Found
Ask a Question
Page 1 of 1