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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 K100203
Device Name HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
SUITE 5D, NO. 19, LANE 999
ZHONGSHAN NO. 2 ROAD(S)
SHANGHAI,  CN 20030
Applicant Contact Diana Hong
Correspondent
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
SUITE 5D, NO. 19, LANE 999
ZHONGSHAN NO. 2 ROAD(S)
SHANGHAI,  CN 20030
Correspondent Contact Diana Hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received01/25/2010
Decision Date 05/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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