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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 K230172
Device Name Pulse Oximeter
Applicant
Beijing Choice Electronic Technology Co., Ltd.
No. 9 Shuangyuan road, Badachu Hi-tech Zone
Shijingshan District
Beijing,  CN 100041
Applicant Contact Haiying Zhao
Correspondent
Beijing Choice Electronic Technology Co., Ltd.
No. 9 Shuangyuan road, Badachu Hi-tech Zone
Shijingshan District
Beijing,  CN 100041
Correspondent Contact Haiying Zhao
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/20/2023
Decision Date 08/12/2023
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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