FDA 510(k) Application Details - K103796

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K103796
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	TELEMEDCARE PTY LTD UNIT 7, 6-8 CREWE PLACE ROSEBERY, NEW SOUTH WALES 2018 AU Other 510(k) Applications for this Company
Contact	STEVEN M MOODY Other 510(k) Applications for this Contact
Regulation Number	870.2910   More FDA Info for this Regulation Number
Classification Product Code	DRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2010
Decision Date	08/03/2011
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