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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mixer, breathing gases, anesthesia inhalation
510(k) Number K142291
Device Name GMX Series Medical Air/Oxygen Blender
Applicant
GENTEC (SHANGHAI) CORPORATION
NO.1988 Yushu Road
Songjiang District,  CN 201699
Applicant Contact Dongjian Lin
Correspondent
Guangzhou Osmunda Medical Device Consulting Co., Ltd
7th floor, 982 Congyun Road
Baiyun District,  CN 510420
Correspondent Contact Mike Gu
Regulation Number868.5330
Classification Product Code
BZR  
Date Received08/18/2014
Decision Date 05/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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