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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 K142832
Device Name Unimed Disposable and Reusable SPO2 Sensors
Applicant
Unimed Medical Supplies, Inc.
#37, Yanshan Rd., Shekou
Shenzhen,  CN 518067
Applicant Contact Xinmei Tan
Correspondent
Unimed Medical Supplies, Inc.
#37, Yanshan Rd., Shekou
Shenzhen,  CN 518067
Correspondent Contact Xinmei Tan
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/30/2014
Decision Date 02/06/2015
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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