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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 K181503
Device Name Fingertip 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 Received06/07/2018
Decision Date 10/11/2018
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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