PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM— 510(k) K110614

Name: FDA 510(k) clearance K110614
Creator: U.S. Food and Drug Administration
Published: 2011-11-21

Substantially Equivalent

Seju Engineering Co., Ltd.

FDA 510(k) clearance K110614 for PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM, Substantially Equivalent on 2011-11-21. Applicant: Seju Engineering Co., Ltd.. Device class: 1.

Clearance details

Applicant: Seju Engineering Co., Ltd.
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2011-03-03
Decision date: 2011-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yuseong-Gu, Daejeon, KR

Download summary PDF View on FDA.gov ↗

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