510(k) K103646

INTELLIVUE MX40 PATIENT MONITOR by Phillips Medical Systems — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2011
Date Received
December 14, 2010
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