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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K172366
Device Name Wrist Pulse Oximeter
Applicant
Beijing Choice Electronic Technology Co., Ltd.
#9 Shuangyuan Rd., Badachu Hi-Tech Zone, Shijingshan Dist
Beijing,  CN 100041
Applicant Contact Lei Chen
Correspondent
Beijing Choice Electronic Technology Co., Ltd.
#9 Shuangyuan Rd., Badachu Hi-Tech Zone, Shijingshan Dist
Beijing,  CN 100041
Correspondent Contact Lei Chen
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/04/2017
Decision Date 03/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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