ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.


Device Classification Name

detector and alarm, arrhythmia

510(k) Number K021251
Device Name ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
Original Applicant
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810

Original Contact dave osborn
Regulation Number 870.1025
Classification Product Code
DSI  
Date Received 04/19/2002
Decision Date 05/07/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No