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510(k) Data Aggregation
K Number
K052804Device Name
BREATHKEY MODEL G10/BREATHKEY MODEL G30X
Manufacturer
OMEGAPOINT SYSTEMS, LLC
Date Cleared
2005-12-09
(66 days)
Product Code
DJZ
Regulation Number
862.3050Why did this record match?
Applicant Name (Manufacturer) :
OMEGAPOINT SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OmegaPoint Systems Personal Breath Alcohol Tester BreathKey™ Model g10 and BreathKey™ Model g30X are indicated for use to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication. BreathKey™ Model g30X transmits the BAC results to an interlock receiver installed in a motor vehicle
Device Description
The OmegaPoint Systems BreathKey™ Model g10 and BreathKey™ Model g30X Personal Breath Alcohol Testers are designed to measure deep lung air to determine the level of alcohol in the blood. BreathKey™ Model g30X is identical to Model g10 except that Model g30X transmits the Blood Alcohol Content (BAC) results by way of a radio frequency signal to an interlock receiver installed in a motor vehicle.
The alcohol sensor is of the electrochemical fuel cell type. As the user's breath moves through the sensor, the sensor generates an electrical current that is proportional to the concentration of ethanol in the breath.
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