AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)— 510(k) K082829

Name: FDA 510(k) clearance K082829
Creator: U.S. Food and Drug Administration
Published: 2008-12-22

Substantially Equivalent

Carleton Life Support Systems, Inc.

FDA 510(k) clearance K082829 for AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS), Substantially Equivalent on 2008-12-22. Applicant: Carleton Life Support Systems, Inc.. Device class: 2.

Clearance details

Applicant: Carleton Life Support Systems, Inc.
Product code: Code OLF
Device class: Class 2
Regulation: 21 CFR 868.5440
Advisory panel: Anesthesiology
Date received: 2008-09-25
Decision date: 2008-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Davenport, IA, US

Download summary PDF View on FDA.gov ↗

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