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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 K133659
Device Name HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
Applicant
Philips Medical Systems
22100 Bothell Everett Way
Bothell,  WA  98021
Applicant Contact JOHN PARDO
Correspondent
Philips Medical Systems
22100 Bothell Everett Way
Bothell,  WA  98021
Correspondent Contact CARLENE COMRIE
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
CCK   DQA   DRO   DXN   LDD  
MHX  
Date Received11/27/2013
Decision Date 01/23/2015
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
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