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FDA 510(k) Application Details - K192404
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
510(K) Number
K192404
Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant
Shenzhen Coreray Technology., Ltd
305, 307 Liangji Building, 1st Donghuan Road
Longhua New District
Shenzhen 518109 CN
Other 510(k) Applications for this Company
Contact
Simon Fan
Other 510(k) Applications for this Contact
Regulation Number
870.2900
More FDA Info for this Regulation Number
Classification Product Code
DSA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/03/2019
Decision Date
06/22/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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