FDA 510(k) Application Details - K130821

Device Classification Name	Transmitters And Receivers, Physiological Signal, Radiofrequency   More FDA Info for this Device
510(K) Number	K130821
Device Name	Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant	INTEL-GE CARE INNOVATIONS LLC 3721 DOUGLAS BOULEVARD SUITE 100 ROSEVILLE, CA 95661 US Other 510(k) Applications for this Company
Contact	MAUREEN GLYNN 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	03/25/2013
Decision Date	08/09/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review