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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact PAUL SCHRADER
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
DQA   DRO   DXN   LDD   MHX  
Date Received03/23/2011
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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