FDA 510(k) Application Details - K133587

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K133587
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	ST. JUDE MEDICAL SYSTEMS AB 4 ROBBINS RD. WESTFORD, MA 01886 US Other 510(k) Applications for this Company
Contact	ERDULFO DE PERALTA 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	11/21/2013
Decision Date	12/20/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review