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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 K062233
Device Name HEARTSTART MRX MONITOR/DEFIBRILLATOR
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
3000 MINUTEMAN ROAD
ANDOVER,  MA  01810 -1099
Applicant Contact MICHAEL J DOYLE
Correspondent
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
3000 MINUTEMAN ROAD
ANDOVER,  MA  01810 -1099
Correspondent Contact MICHAEL J DOYLE
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
CCK   DPS   DQA   DRO   DXN  
LDD   LIX   MSX   MWI  
Date Received08/02/2006
Decision Date 11/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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