EZ-OX PLUS GENERATION II— 510(k) K131386

Name: FDA 510(k) clearance K131386
Creator: U.S. Food and Drug Administration
Published: 2014-03-14

Substantially Equivalent

Air Liquide Healthcare America

FDA 510(k) clearance K131386 for EZ-OX PLUS GENERATION II, Substantially Equivalent on 2014-03-14. Applicant: Air Liquide Healthcare America. Device class: 1.

Clearance details

Applicant: Air Liquide Healthcare America
Product code: Code ECX
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 2013-05-14
Decision date: 2014-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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