FDA 510(k) Application Details - K172797

Device Classification Name	Cable, Transducer And Electrode, Patient, (Including Connector)   More FDA Info for this Device
510(K) Number	K172797
Device Name	Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant	Shenzhen Coreray Technology., Ltd ChuangYe Technology Park,1th Dong Huan 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	09/15/2017
Decision Date	02/28/2018
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