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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
Contec Medical System Co., Ltd.
No. 112 Qinhuang West Street, Economic & Technical
Development Zone
Qinhuangdao,  CN 066004
Applicant Contact Xueyong Li
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd.,
FanShan District,
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number868.5440
Classification Product Code
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