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510(k) Data Aggregation
K Number
K052448Device Name
POCKET BREATHALYZER. CONNECTABLES
Manufacturer
CONNECTABLES, LLC
Date Cleared
2006-02-23
(169 days)
Product Code
DJZ, CLA
Regulation Number
862.3050Why did this record match?
Applicant Name (Manufacturer) :
CONNECTABLES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to measure alcohol in the human breath. Measurements obtained by this device are used as an aid in the detection of alcohol intoxication.
Device Description
The Connectables® Alcohol Tester 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 Connectables® Alcohol Tester is an alcohol screening device and uses a blow time of 3 seconds to capture an accurate deep lung sample. The Connectables® Alcohol Tester contains a semiconductor sensor designed to test for the presence of alcohol. The 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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