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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 K070371
Device Name FINGERTIP PULSE OXIMETER MD300C
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
SUITE 8D ZHONGXIN ZHONGSHAN
MANSION, NO. 19 LANE, 999
SHANGHAI, SHANGHAI,  CN 20020
Applicant Contact Diana Hong
Correspondent
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
SUITE 8D ZHONGXIN ZHONGSHAN
MANSION, NO. 19 LANE, 999
SHANGHAI, SHANGHAI,  CN 20020
Correspondent Contact Diana Hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/08/2007
Decision Date 08/13/2007
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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