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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 K173368
Device Name Reusable & Disposable SpO2 Sensors
Applicant
Shenzhen Coreray Technology, Ltd.
Chuangye Technology Park
1th Dong Huan Rd., Longhua New District
Shenzhen,  CN 518109
Applicant Contact Simon Fan
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1122#, International Mmayor Communication Center
Shizhou Zhong Rd. 55#, Na
Shenzhen,  CN 518100
Correspondent Contact Field Fu
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/26/2017
Decision Date 08/31/2018
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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