BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000— 510(k) K061922

Name: FDA 510(k) clearance K061922
Creator: U.S. Food and Drug Administration
Published: 2006-10-30

Substantially Equivalent

Sentech Korea Corp.

FDA 510(k) clearance K061922 for BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000, Substantially Equivalent on 2006-10-30. Applicant: Sentech Korea Corp.. Device class: 1.

Clearance details

Applicant: Sentech Korea Corp.
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2006-07-07
Decision date: 2006-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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