510(k) K131872

INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550 by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2013
Date Received
June 24, 2013
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