510(k) K111905

INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN — Product Code DXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2011
Date Received
July 5, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Cathode-Ray Tube, Medical
Device Class
Class II
Regulation Number
870.2450
Review Panel
CV
Submission Type