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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 K161560
Device Name Fingertip Pulse Oximeter MD300CN310
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
NO.9 SHUANGYUAN ROAD, BADACHU HI-TECH ZONE
SHIJINGSHAN DISTRICT
Beijing,  CN 100041
Applicant Contact LEI CHEN
Correspondent
BEIJING CHOICE ELECTRONIC TECHNOLOGY 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 Received06/06/2016
Decision Date 10/05/2016
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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