BACTRACK LCD ALCOHOL DETECTOR

Devices, Breath Trapping, Alcohol

KHN SOLUTIONS, LLC

The following data is part of a premarket notification filed by Khn Solutions, Llc with the FDA for Bactrack Lcd Alcohol Detector.

Pre-market Notification Details

Device IDK071067
510k NumberK071067
Device Name:BACTRACK LCD ALCOHOL DETECTOR
ClassificationDevices, Breath Trapping, Alcohol
Applicant KHN SOLUTIONS, LLC P.O. BOX 7007 Deerfield,  IL  60015
ContactDaniel Kamm
CorrespondentDaniel Kamm
KHN SOLUTIONS, LLC P.O. BOX 7007 Deerfield,  IL  60015
Product CodeDJZ  
CFR Regulation Number862.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-16
Decision Date2007-09-14
Summary:summary

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