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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
Recalls CDRH Recalls
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