ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR


Device Classification Name

devices, breath trapping, alcohol

510(k) Number K080848
Device Name ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR
Applicant
Q3 INNOVATIONS, LLC
p.o. box 7007
deerfield, 
IL 
60015

Applicant Contact daniel kamm
Correspondent
Q3 INNOVATIONS, LLC
p.o. box 7007
deerfield, 
IL 
60015

Correspodent Contact daniel kamm
Regulation Number 862.3050
Classification Product Code
DJZ  
Date Received 03/26/2008
Decision Date 07/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No