FDA 510(k) Application Details - K090556

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K090556
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	SPACELABS HEALTHCARE MEDICAL EQUIPMENT (SUZHOU) CO P.O. BOX 3018 NEDERLAND, CO 80466 US Other 510(k) Applications for this Company
Contact	THOMAS KROENKE 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	03/02/2009
Decision Date	04/30/2009
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