ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579— 510(k) K091714

Name: FDA 510(k) clearance K091714
Creator: U.S. Food and Drug Administration
Published: 2009-11-18

Substantially Equivalent

Skyfine Inc. Limited

FDA 510(k) clearance K091714 for ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579, Substantially Equivalent on 2009-11-18. Applicant: Skyfine Inc. Limited. Device class: 1.

Clearance details

Applicant: Skyfine Inc. Limited
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2009-06-10
Decision date: 2009-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei County, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.