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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 K051134
Device Name HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A
Applicant
PHILIPS MEDICAL SYSTEMS
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Applicant Contact DANIEL J DILLON
Correspondent
PHILIPS MEDICAL SYSTEMS
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Correspondent Contact DANIEL J DILLON
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
CCK   DPS   DQA   DRO   DXN  
LDD   LIX   MWI  
Date Received05/03/2005
Decision Date 09/08/2005
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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