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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 K972418
Device Name HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)
Applicant
Heartstream, Inc.
2401 Fourth Ave., Suite 300
Seattle,  WA  98121
Applicant Contact CINDY PESTKA
Correspondent
Heartstream, Inc.
2401 Fourth Ave., Suite 300
Seattle,  WA  98121
Correspondent Contact CINDY PESTKA
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received06/27/1997
Decision Date 09/25/1997
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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