510(k) K130849

INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2013
Date Received
March 26, 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