FDA 510(k) Application Details - K142476

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K142476
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	HealthWatch Ltd. 6 Hasadna Street Kfar Saba 44424 IL Other 510(k) Applications for this Company
Contact	Yoram Levy Other 510(k) Applications for this Contact
Regulation Number	870.2920   More FDA Info for this Regulation Number
Classification Product Code	DXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2014
Decision Date	02/17/2015
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