STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0


Device Classification Name

monitor, st segment with alarm

510(k) Number K080461
Device Name STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
Applicant
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

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

Correspodent Contact zety billard
Regulation Number 870.1025
Classification Product Code
MLD  
Subsequent Product Codes
DSI   MHX  
Date Received 02/20/2008
Decision Date 03/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No