GMX Series Medical Air/Oxygen Blender— 510(k) K142291

Name: FDA 510(k) clearance K142291
Creator: U.S. Food and Drug Administration
Published: 2015-05-19

Substantially Equivalent

Gentec (Shanghai) Corporation

FDA 510(k) clearance K142291 for GMX Series Medical Air/Oxygen Blender, Substantially Equivalent on 2015-05-19. Applicant: Gentec (Shanghai) Corporation. Device class: 2.

Clearance details

Applicant: Gentec (Shanghai) Corporation
Product code: Code BZR
Device class: Class 2
Regulation: 21 CFR 868.5330
Advisory panel: Anesthesiology
Date received: 2014-08-18
Decision date: 2015-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Songjiang District, CN

Download summary PDF View on FDA.gov ↗

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