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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 K123871
Device Name FINGERTIP PULSE OXIMETER
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
NORTH BUILDING 3F, NO.9
SHUANGYUAN RD., BADACHU HITECH
SHIJINGSHAN DISTRICT, BEIJING,  CN 100041
Applicant Contact LEI CHEN
Correspondent
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
NORTH BUILDING 3F, NO.9
SHUANGYUAN RD., BADACHU HITECH
SHIJINGSHAN DISTRICT, BEIJING,  CN 100041
Correspondent Contact LEI CHEN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/17/2012
Decision Date 05/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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