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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 K970741
Device Name POWERHEART AECD
Applicant
Cardiac Science, Inc.
1176 Main St., Bldg. C
Irvine,  CA  92614
Applicant Contact RAYMOND COHEN
Correspondent
Cardiac Science, Inc.
1176 Main St., Bldg. C
Irvine,  CA  92614
Correspondent Contact RAYMOND COHEN
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received02/28/1997
Decision Date 10/16/1997
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
Recalls CDRH Recalls
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