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510(k) Data Aggregation
K Number
K963608Device Name
QUANTITATIVE SENTINEL SYSTEM
Manufacturer
QUANTITATIVE MEDICINE, INC.
Date Cleared
1997-03-11
(182 days)
Product Code
HGM
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
QUANTITATIVE MEDICINE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantitative Sentinel (QS) System is a software application that is intended for use as clinical data management system (also referred to as a clinical information system - CIS). The primary function of the system is the management of clinical data (whether manually or automatically acquired) for the purpose of providing integrated, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The OS System serves as a decision support tool as well as an electronic medical record.
Device Description
The Quantitative Sentinel (QS) System is a software application that is intended for use as clinical data management system (also referred to as a clinical information system - CIS). The primary function of the system is the management of clinical data (whether manually or automatically acquired) for the purpose of providing integrated, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The OS System serves as a decision support tool as well as an electronic medical record. The QS System operates on off-the-shelf software and hardware.
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K Number
K960109Device Name
QUANTITATIVE SENTINEL SYSTEM
Manufacturer
QUANTITATIVE MEDICINE, INC.
Date Cleared
1996-08-01
(203 days)
Product Code
HGM
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
QUANTITATIVE MEDICINE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantitative Sentinel (QS) System is a software application that is intended for use as clinical data management system (also referred to as a clinical information system - CIS). The primary function of the system is the management of clinical data (whether manually or automatically acquired) for the purpose of providing integrated, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The QS System serves as a decision support tool as well as an electronic medical record. The device is intended for use in a hospital/clinical environment.
Device Description
The Quantitative Sentinel (QS) System is a software application that is intended for use as clinical data management system (also referred to as a clinical information system - CIS). The primary function of the system is the management of clinical data (whether manually or automatically acquired) for the purpose of providing integrated, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The QS System serves as a decision support tool as well as an electronic medical record. The QS System operates on off-the-shelf software and hardware. The device is intended for use in a hospital/clinical environment.
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