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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 K181270
Device Name Disposable SpO2 Sensors, Reusable SpO2 Sensors
Applicant
Orantech, Inc.
Zone#A, 4f, 1st Bld, 7th Industrial Zone, Yulv Community,
Gongming
Shenzhen,  CN 518132
Applicant Contact Yunxi Xiong
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/14/2018
Decision Date 09/07/2018
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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