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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 Rd.
Andover,  MA  01810 -1099
Applicant Contact MICHAEL J DOYLE
Correspondent
Philips Medical Systems North America, Inc.
3000 Minuteman Rd.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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