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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 K072825
Device Name FINGERTIP PULSE OXIMETER, MODEL MD300I
Applicant
Beijing Choice Electronic Technololgy Co., Ltd.
Suite 8d, Zhongxin Zhongshan
No19, Ln999, Zhong Shan Nan Er
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Beijing Choice Electronic Technololgy Co., Ltd.
Suite 8d, Zhongxin Zhongshan
No19, Ln999, Zhong Shan Nan Er
Shanghai,  CN 200030
Correspondent Contact Diana Hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/02/2007
Decision Date 01/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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