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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 K993533
Device Name POWERHEART AECD
Applicant
CARDIAC SCIENCE, INC.
16931 MILLIKAN AVE.
IRVINE,  CA  92606
Applicant Contact STAN E TILLMAN
Correspondent
CARDIAC SCIENCE, INC.
16931 MILLIKAN AVE.
IRVINE,  CA  92606
Correspondent Contact STAN E TILLMAN
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Code
LDD  
Date Received10/19/1999
Decision Date 01/24/2000
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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