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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
Recalls CDRH Recalls
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