PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521

Device Classification Name

system,network and communication,physiological monitors

510(k) Number K071391
Device Name PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
Applicant
PHILIPS MEDICAL SYSTEMS, INC.
3000 minuteman rd.
andover, 
MA 
01810

Applicant Contact paul schrader
Correspondent
PHILIPS MEDICAL SYSTEMS, INC.
3000 minuteman rd.
andover, 
MA 
01810

Correspodent Contact paul schrader
Regulation Number 870.2300
Classification Product Code
MSX  
Date Received 05/18/2007
Decision Date 09/07/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No