M2376 DEVICELINK SYSTEM


Device Classification Name

monitor,physiological,patient(without arrhythmia detection or alarms)

510(k) Number K021912
Device Name M2376 DEVICELINK SYSTEM
Original Applicant
PHILIPS MEDICAL SYSTEMS, INC.
3000 minuteman rd.
andover, 
MA 
01810

Original Contact denise hadley
Regulation Number 870.2300
Classification Product Code
MWI  
Date Received 06/11/2002
Decision Date 06/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No