FDA 510(k) Application Details - K150329

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K150329
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	SPACELABS HEALTHCARE 35301 SE CENTER STREET SNOQUALMIE, WA 98065 US Other 510(k) Applications for this Company
Contact	Al Van Houdt 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	02/10/2015
Decision Date	11/05/2015
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