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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K171828
Device Name ETCO2 Sensor
Applicant
Orantech, Inc.
Zone#A,4f,1st Bld, 7th Industrial Zone
Yulv Community, Gongming, Guangming
Shenzhen,  CN 518106
Applicant Contact Yunxi Xiong
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
22a, Haijing Sq., #18 Taizi Rd., Nanshan District
Shenzhen,  CN 51800
Correspondent Contact Mei Mei
Regulation Number868.1400
Classification Product Code
CCK  
Date Received06/20/2017
Decision Date 05/31/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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