RMI LCD ALCOHOL DETECTOR— 510(k) K062545

Name: FDA 510(k) clearance K062545
Creator: U.S. Food and Drug Administration
Published: 2007-04-09

Substantially Equivalent

Resource Management International, LLC

FDA 510(k) clearance K062545 for RMI LCD ALCOHOL DETECTOR, Substantially Equivalent on 2007-04-09. Applicant: Resource Management International, LLC. Device class: 1.

Clearance details

Applicant: Resource Management International, LLC
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2006-08-30
Decision date: 2007-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukegan, IL, US

Download summary PDF View on FDA.gov ↗

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