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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
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