510(k) K082583

INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5 by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2009
Date Received
September 8, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type