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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
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