FDA 510(k) Application Details - K103432

Device Classification Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K103432
Device Name	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC 8200 WEST TOWER AVENUE MILWAUKEE, WI 53223 US Other 510(k) Applications for this Company
Contact	ROBERT CASARSA Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	MWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2010
Decision Date	12/17/2010
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