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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 K081125
Device Name WRIST PULSE OXIMETER MD300W
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
ROOM 1127-1128 BUILDING B
BAILANGYUAN FUXING RD. #A36
BEIJING,  CN 100041
Applicant Contact LEI WANG
Correspondent
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
ROOM 1127-1128 BUILDING B
BAILANGYUAN FUXING RD. #A36
BEIJING,  CN 100041
Correspondent Contact LEI WANG
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/21/2008
Decision Date 07/02/2008
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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