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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 K003819
Device Name HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
Applicant
Agilent Technologies, Inc.
2401 Fourth Ave., Suite 500
Seattle,  WA  98121
Applicant Contact TERESA SKARR
Correspondent
Agilent Technologies, Inc.
2401 Fourth Ave., Suite 500
Seattle,  WA  98121
Correspondent Contact TERESA SKARR
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Code
MLN  
Date Received12/11/2000
Decision Date 05/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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