FDA 510(k) Application Details - K082045

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K082045
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	SPACELABS MEDICAL INC. 2235 EAST FLAMINGO RD. SUITE 201G LAS VEGAS, NV 89119 US Other 510(k) Applications for this Company
Contact	TIM DAVIS 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	07/18/2008
Decision Date	08/01/2008
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