FDA 510(k) Application Details - K182327

Device Classification Name	Cable, Transducer And Electrode, Patient, (Including Connector)   More FDA Info for this Device
510(K) Number	K182327
Device Name	Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant	Orantech Inc. Zone#A, 4F, 1st Bld, 7th Industrial Zone Yulv Community, GongMing Shenzhen 518106 CN Other 510(k) Applications for this Company
Contact	Hsin Xiong 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	08/27/2018
Decision Date	01/30/2019
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