FDA 510(k) Application Details - K150975

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K150975
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH Hewlett-Packard Str. 2 Boeblingen, Baden Wuerttemberg 71034 DE Other 510(k) Applications for this Company
Contact	Michael Asmalsky 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	04/13/2015
Decision Date	06/25/2015
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