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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 K082487
Device Name M-50 SERIES SPO2 SENSOR
Applicant
Beijing Choice Electronic Technololgy Co., Ltd.
Rm. 1127-1128 Bldg. B
Bailangyuan Fuxing Rd. #A36
Beijing,  CN 100039
Applicant Contact LEI CHEN
Correspondent
Beijing Choice Electronic Technololgy Co., Ltd.
Rm. 1127-1128 Bldg. B
Bailangyuan Fuxing Rd. #A36
Beijing,  CN 100039
Correspondent Contact LEI CHEN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/28/2008
Decision Date 03/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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