FDA 510(k) Application Details - K153188

Device Classification Name	Cable, Transducer And Electrode, Patient, (Including Connector)   More FDA Info for this Device
510(K) Number	K153188
Device Name	Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant	SHENZHEN CAREMED MEDICAL TECHNOLOGY CO., LTD. ZONE B, 3/F, 11 BUILDING, HEBEI INDUSTRIAL AREA, LONGHUA OFFICE, LONGHUA NEW D SHENZHEN 518021 CN Other 510(k) Applications for this Company
Contact	XINLIN XIAO 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	11/03/2015
Decision Date	10/24/2016
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