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510(k) Data Aggregation
K Number
K080848Device Name
ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR
Manufacturer
Q3 INNOVATIONS, LLC
Date Cleared
2008-07-25
(121 days)
Product Code
DJZ
Regulation Number
862.3050Why did this record match?
Applicant Name (Manufacturer) :
Q3 INNOVATIONS, LLC
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 AlcoHAWK® PT500 is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The AlcoHAWK® PT500 has been tested and uses a blow time of 5 seconds to capture an accurate deep lung sample. The AlcoHAWK® PT500 sensor uses a fuel cell type of detector similar to one found on professional units. It is handheld and uses two AA alkaline batteries as a power source. The mouthpiece is replaceable Plexiglas plastic.
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K Number
K043188Device Name
ALCOHAWK PRECISION
Manufacturer
Q3 INNOVATIONS, LLC
Date Cleared
2005-02-09
(84 days)
Product Code
DJZ
Regulation Number
862.3050Why did this record match?
Applicant Name (Manufacturer) :
Q3 INNOVATIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Device Description
The Alcohawk Precision™ is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The Alcohawk Precision™ is a D.O.T. approved alcohol screening device and uses a blow time of 5 seconds to capture an accurate deep lung sample. The Alcohawk Precision™ contains a semiconductor oxide sensor designed to test for the presence of alcohol. Gas sensitive semiconductor material is formed on an alumina substrate on which the gold electrodes are printed. A thick film heater of ruthenium oxide is printed on the reverse of the substrate and placed in the plastic housing. The tin dioxide (SnO2) metal oxide semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.
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