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K Number
K053332
Device Name
BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500
Manufacturer
SENTECH KOREA CORP.
Date Cleared
2006-01-20

(50 days)

Product Code
DJZ
Regulation Number
862.3050
Type
Traditional
Panel
TX
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 862.3050 Breath-alcohol test system.

(a)
Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.