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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 K152563
Device Name Pulse Oximeter (MD300M/MD300K2)
Applicant
Beijing Choice Electronic Technology Co., Ltd.
#9 Shuangyuan Rd., Badachu Hi-Tech Zone, Shijingshan
District
Beijing,  CN 100041
Applicant Contact LEI CHEN
Correspondent
Beijing Choice Electronic Technology Co., Ltd.
#9 Shuangyuan Rd., Badachu Hi-Tech Zone, Shijingshan
District
Beijing,  CN 100041
Correspondent Contact LEI CHEN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/09/2015
Decision Date 04/18/2016
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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