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510(k) Data Aggregation
K Number
K011741Device Name
CRIT-LINE MONITOR III TQA (CLM TQA)
Manufacturer
HEMAMETRICS
Date Cleared
2002-07-23
(413 days)
Product Code
FIL
Regulation Number
876.5820Why did this record match?
Product Code :
FIL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the CRIT-LINE III TQA Monitor is as a non-invasive hematocrit, oxygen saturation, and percent change in blood volume monitor. The CRIT-LINE III TQA Monitor also non-invasively estimates access recirculation and non-invasively estimates access blood flow. In addition, the CLM III TQA Monitor calculates an estimated Urea Reduction Ratio based on relative changes in urea nitrogen concentration in the spent dialysate.
Device Description
The CRIT-LINE III TQA is an FDA cleared device that non-invasively measures Hct, O2 Sat, Percent Change in Blood Volume. The CLM III TOA also estimates Access Recirculation and Access Blood Flow. The URR sensor is an additional attachment to the CRIT-LINE III TOA. The optical light emitted by the URR sensor is directed through the spent dialysate stream and absorbed by the constituents of the spent dialysate. The transmitted light is then detected and the relative urea nitrogen concentration in the spent dialysate is calculated.
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