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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K180837
Device Name CONTEC Oxygen Concentrator
Applicant
Contec Medical System Co., Ltd.
#112 Qinhuang W. St.
Economic & Technical Development Zone
Qinhuangdao,  CN 066004
Applicant Contact Xueyong Li
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui, #5, Yihe N. Rd.,
Fanshan District,
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number868.5440
Classification Product Code
CAW  
Date Received03/30/2018
Decision Date 01/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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