FDA 510(k) Application Details - K091594

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K091594
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH 9900 Innovation Drive Wauwatosa, WI 53226 US Other 510(k) Applications for this Company
Contact	PATRICIA TAIGE Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/2009
Decision Date	07/29/2009
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	N
Expedited Review