Medipure Oxygen-LC System— 510(k) K153518

Name: FDA 510(k) clearance K153518
Creator: U.S. Food and Drug Administration
Published: 2016-06-03

Substantially Equivalent

Praxair Distribution, Incorporated.

FDA 510(k) clearance K153518 for Medipure Oxygen-LC System, Substantially Equivalent on 2016-06-03. Applicant: Praxair Distribution, Incorporated.. Device class: 1.

Clearance details

Applicant: Praxair Distribution, Incorporated.
Product code: Code ECX
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 2015-12-08
Decision date: 2016-06-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Tonawanda, NY, US

Download summary PDF View on FDA.gov ↗

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