FDA 510(k) Application Details - K092635

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K092635
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	ALCATEL-LUCENT CANADA INC. 1380 RODICK RD. MARKHAM, ON L3R 4G5 CA Other 510(k) Applications for this Company
Contact	ALEX GIOSA 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	08/27/2009
Decision Date	09/10/2009
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	Y
Expedited Review