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510(k) Data Aggregation
K Number
K091714Device Name
ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579
Manufacturer
SKYFINE INC. LIMITED
Date Cleared
2009-11-18
(161 days)
Product Code
DJZ
Regulation Number
862.3050Why did this record match?
Applicant Name (Manufacturer) :
SKYFINE INC. LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Device Description
The AlcoDigital Breathalyzer AT576, AT577, AT578, AT579 are designed to measure deep lung air to determine the level of alcohol in the blood. The relationship between alcohol in the blood and in the deep lung breath is well established by Henry's law in ratio of 2100:1. The alcohol sensor is electrochemical fuel cell type, and the unit has been designed to blow 6 seconds to get the sample of alcohol, the sensor generates an output by electronic voltage, which is proportional to the concentration of alcohol in the blood. The unit is powered by 1 pcs 9V battery or DC12V input.
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