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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.
No.9 Shuangyuan road, Badachu Hi-tech Zone, Shijingshan Dist
Beijing,  CN 100041
Applicant Contact Lei Chen
Correspondent
Beijing Choice Electronic Technology Co., Ltd.
No.9 Shuangyuan road, 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
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