REDLINE ALCOHOL BREATH TESTER— 510(k) K072953

Name: FDA 510(k) clearance K072953
Creator: U.S. Food and Drug Administration
Published: 2008-01-07

Substantially Equivalent

Redline Products (Pty) , Ltd.

FDA 510(k) clearance K072953 for REDLINE ALCOHOL BREATH TESTER, Substantially Equivalent on 2008-01-07. Applicant: Redline Products (Pty) , Ltd.. Device class: 1.

Clearance details

Applicant: Redline Products (Pty) , Ltd.
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2007-10-18
Decision date: 2008-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Strand Industria, Western Cape, ZA

Download summary PDF View on FDA.gov ↗

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