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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name display, cathode-ray tube, medical
510(k) Number K111905
Device Name INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216
Applicant
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
HEWLETT-PACKARD STR.2
BOEBLINGEN,  DE D 71034
Applicant Contact MARKUS STACHA
Correspondent
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
HEWLETT-PACKARD STR.2
BOEBLINGEN,  DE D 71034
Correspondent Contact MARKUS STACHA
Regulation Number870.2450
Classification Product Code
DXJ  
Subsequent Product Codes
DQA   DRG   DRQ   DRT   DSA  
DSI   DSJ   DSK   DXG   DXN   DXQ  
MSX  
Date Received07/05/2011
Decision Date 10/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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