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510(k) Data Aggregation
K Number
K062977Device Name
CRITIVIEW, MODEL CRV3
Manufacturer
CRITISENSE LTD.
Date Cleared
2007-02-28
(152 days)
Product Code
DPW, EZL, KHO
Regulation Number
870.2100Why did this record match?
Applicant Name (Manufacturer) :
CRITISENSE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CritiView Device is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in the measured parameters--blood flow change, blood volume change, and NADH concentration change-- provide information on tissue metabolic activity.
Tissues which may be monitored are: brain, liver, kidney, intestine, testis, skin, and urethra. Note that heart may not be used as the heart beating motion may not provide a reliable probe contact surface.
Device Description
The CritiView device carries out certain in-vivo, spectroscopic measurements and displays them as a trend. The parameters measured are blood flow change, blood volume change, and NADH concentration change. It is a multi-parametric monitoring device intended for the measurement of tissue metabolic state. The Criti View device consists of NADH Fluorometer and Doppler Flowmeter. The CritiView (CRV3) device is a modification of the predicate, CritiView, K051145. Measurements are made with the use of optical probes, i.e. pencil type for direct tissue contact and Foley catheter for measurement on the urethral wall tissue.
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K Number
K051145Device Name
CRITIVIEW
Manufacturer
CRITISENSE LTD.
Date Cleared
2006-01-18
(259 days)
Product Code
DPW
Regulation Number
870.2100Why did this record match?
Applicant Name (Manufacturer) :
CRITISENSE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CritiView is indicated for in-vivo monitoring of changes in NADH redox state and microvascular perfusion in tissue. Changes in the measured parameters, blood flow change, blood volume change, and NADH concentration change provide information on tissue metabolic activity. The CritiView uses a pencil style probe which is in contact with the tissue(s) to be measured / monitored. The device may be used for up to eight (8) hours per twenty-four (24) hour period. Tissues which may be monitored are: brain, liver, kidney, intestine, testis, skin. Note that heart may not be used, as the heart beating motion may not provide a reliable probe contact surface. Environment of use include - hospital - OR, ICU, Emergency Departments, High Dependency Units Institutions
Device Description
The CritiView device carries out certain in-vivo, spectroscopic measurements and displays them as a trend. The parameters measured are blood flow change, blood volume change, and NADH concentration change. It is a multi-parametric monitoring device intended for the measurement of tissue metabolic state. The CritiView device consists of NADH Fluorometer and Doppler Flowmeter. The CritiView device is a modification of the predicate, Tissue Spectroscope (K992529).
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