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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 K152390
Device Name Medke Oximetry Finger Sensor
Applicant
Shenzhen Medke Technology Co., Ltd.
4/F,Bldg.A1,Anle Ind. Zone,Hangcheng Rd.., Baoan Dist
Shenzhen,  CN 518126
Applicant Contact Lao Chengxin
Correspondent
Shenzhen Medke Technology Co., Ltd.
4/F,Bldg.A1,Anle Ind. Zone,Hangcheng Rd.., Baoan Dist
Shenzhen,  CN 518126
Correspondent Contact Lao Chengxin
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/24/2015
Decision Date 08/18/2016
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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