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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 K122046
Model MD300W4
Device Name WRIST PULSE OXIMETER
Original Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
no. 9 shuangyuan rd.
shijingshan district
beijing,  CH 100041
Original Contact lei chen
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/12/2012
Decision Date 02/04/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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