FDA 510(k) Application Details - K131585

Device Classification Name	Monitor, Bed Patient   More FDA Info for this Device
510(K) Number	K131585
Device Name	Monitor, Bed Patient
Applicant	INTEL-GE CARE INNOVATIONS LLC 1721 DOUGLAS BLVD 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	880.2400   More FDA Info for this Regulation Number
Classification Product Code	KMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2013
Decision Date	10/08/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review