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FDA 510(k) Application Details - K201359
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
510(K) Number
K201359
Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant
Xinkang Medical Instrument Co., Ltd
2 Floor, Puhua Science and Technology Park, Tongsheng
Community Dalang
Shenzhen 518109 CN
Other 510(k) Applications for this Company
Contact
Xu Changsheng
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
05/21/2020
Decision Date
10/01/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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