MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM— 510(k) K033897

Name: FDA 510(k) clearance K033897
Creator: U.S. Food and Drug Administration
Published: 2004-07-19

Substantially Equivalent

Aga-Linde Health Care

FDA 510(k) clearance K033897 for MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM, Substantially Equivalent on 2004-07-19. Applicant: Aga-Linde Health Care. Device class: 1.

Clearance details

Applicant: Aga-Linde Health Care
Product code: Code ECX
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 2003-12-16
Decision date: 2004-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, US

Download summary PDF View on FDA.gov ↗

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