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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 K142888
Device Name Fingertip Pulse Oximeter
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
No.9 Shuangyuan Road, Badachu Hi-tech Zone,
Shijingshan District
BEIJING,  CN 100041
Applicant Contact Lei Chen
Correspondent
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
No.9 Shuangyuan Road, Badachu Hi-tech Zone,
Shijingshan District
BEIJING,  CN 100041
Correspondent Contact Lei Chen
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/02/2014
Decision Date 02/20/2015
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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