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510(k) K081855

Device
IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)
Applicant
Canada, Inc.
510(k) number
K081855
Product code
DJZ
Decision
Substantially Equivalent (SESE)
Decision date
2008-12-19
Date received
2008-06-30
Regulation
862.3050
Classification name
Devices, Breath Trapping, Alcohol
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
FEDERICO FORERO
Address
1100 Hammond Dr. Suite 410a-223 Atlanta GA US 30328 30328

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K090766LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTERLifeloc Technologies, Inc.2009-07-23
K082080ALCO TUBE PLUSAlcotest Quebec2009-04-01
K090067BACTRACK SELECT BREATHALYZER, MODEL S80Khn Solutions, LLC2009-03-24
K083801BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70Khn Solutions, LLC2009-03-19
K082086KEY RING ALCOHOL BREATHALYZERThe Ashley Collection, Inc.2008-12-19
K080848ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTORQ3 Innovations, LLC2008-07-25
K063443DRAEGER ALCOTEST 6510Drager Safety2008-03-11