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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
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