M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O


Device Classification Name

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

510(k) Number K023698
Device Name M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O
Original Applicant
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

Original Contact david osborn
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 11/04/2002
Decision Date 11/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls