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OTC - Over The Counter
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Document NumberK041334
Test Name KHN SOLUTIONS LLC ALCOMATE MODEL CA2000 NON-INVASIVE DIGITAL BREATH ALCOHOL METER  
Manufacturer NameKHN SOLUTIONS, LLC
Consumer Information Phone Number(877)334-6876
Test TypeAlcohol, breath
Effective Date08/11/2004
Device Classification Name Devices, Breath Trapping, Alcohol
510(k) Number K041334
Device Name ALCOMATE, MODEL CA2000
Applicant
KHN SOLUTIONS, LLC
P.O. BOX 7007
DEERFIELD,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
KHN SOLUTIONS, LLC
P.O. BOX 7007
DEERFIELD,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received05/19/2004
Decision Date 08/11/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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