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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 K211400
Device Name Pulse Oximeter
Applicant
Beijing Choice Electronic Technology Co., Ltd.
#9 Shuangyuan Rd., Badachu Hi-Tech Zone, Shijingshan
District
Beijing,  CN 100041
Applicant Contact Haiying Zhao
Correspondent
Beijing Choice Electronic Technology Co., Ltd.
#9 Shuangyuan Rd., Badachu Hi-Tech Zone, Shijingshan
District
Beijing,  CN 100041
Correspondent Contact Haiying Zhao
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/05/2021
Decision Date 02/11/2022
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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