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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K192404
Device Name Patient Monitoring Cable (SpO2 Extension Cable)
Applicant
Shenzhen Coreray Technology, Ltd.
305, 307 Liangji Bldg., 1st Donghuan Rd.
Longhua New District
Shenzhen,  CN 518109
Applicant Contact Simon Fan
Correspondent
Shenzhen Coreray Technology, Ltd.
305, 307 Liangji Bldg., 1st Donghuan Rd.
Longhua New District
Shenzhen,  CN 518109
Correspondent Contact Simon Fan
Regulation Number870.2900
Classification Product Code
DSA  
Date Received09/03/2019
Decision Date 06/22/2020
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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