M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00


Device Classification Name

monitor, physiological, patient(with arrhythmia detection or alarms)

510(k) Number K050742
Device Name M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00
Applicant
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

Applicant Contact david osborn
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

Correspodent Contact david osborn
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 03/22/2005
Decision Date 04/05/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No