PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K110825
Device Name PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES
Applicant
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover, 
MA 
01810 -1099

Applicant Contact paul schrader
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover, 
MA 
01810 -1099

Correspodent Contact paul schrader
Regulation Number 870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
DQA   DRO   DXN   LDD   MHX  
Date Received 03/23/2011
Decision Date 02/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls