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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 K003565
Device Name HEARTSTREAM FR2 AED, MODEL M3860A,M3861A
Applicant
Agilent Technologies, Inc.
2401 Fourth Ave., Suite 500
Seattle,  WA  98121
Applicant Contact GRETCHEN SOLBERG
Correspondent
Agilent Technologies, Inc.
2401 Fourth Ave., Suite 500
Seattle,  WA  98121
Correspondent Contact GRETCHEN SOLBERG
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received11/20/2000
Decision Date 12/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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