POCKET BREATHALYZER. CONNECTABLES— 510(k) K052448

Name: FDA 510(k) clearance K052448
Creator: U.S. Food and Drug Administration
Published: 2006-02-23

Substantially Equivalent

Connectables, LLC

FDA 510(k) clearance K052448 for POCKET BREATHALYZER. CONNECTABLES, Substantially Equivalent on 2006-02-23. Applicant: Connectables, LLC. Device class: 1.

Clearance details

Applicant: Connectables, LLC
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2005-09-07
Decision date: 2006-02-23
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.