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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 K141362
Device Name PULSE OXIMETER CMS50EW
Applicant
Contec Medical Systems Co.,Ltd
P.O. Box 120-119
Shanghai,  CN 200120
Applicant Contact Diana Hong
Correspondent
Contec Medical Systems Co.,Ltd
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/23/2014
Decision Date 04/23/2015
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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