ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR— 510(k) K080848

Name: FDA 510(k) clearance K080848
Creator: U.S. Food and Drug Administration
Published: 2008-07-25

Substantially Equivalent

Q3 Innovations, LLC

FDA 510(k) clearance K080848 for ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR, Substantially Equivalent on 2008-07-25. Applicant: Q3 Innovations, LLC. Device class: 1.

Clearance details

Applicant: Q3 Innovations, LLC
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2008-03-26
Decision date: 2008-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

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