FDA 510(k) Application Details - K170536

Device Classification Name	Cable, Transducer And Electrode, Patient, (Including Connector)   More FDA Info for this Device
510(K) Number	K170536
Device Name	Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant	APK Technology Co., Ltd. 6Floor, B2 Building, Industry of Hengfeng Hezhou, Xixiang, Bao'an Distric Shenzhen 518126 CN Other 510(k) Applications for this Company
Contact	Caifang Wang 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	02/23/2017
Decision Date	04/24/2017
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