INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216


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

Correspodent Contact markus stacha
Regulation Number 870.2450
Classification Product Code
DXJ  
Subsequent Product Codes
DQA   DRG   DRQ   DRT   DSA  
DSI   DSJ   DSK   DXG   DXN   DXQ  
MSX  
Date Received 07/05/2011
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