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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
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