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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 K982710
Device Name AECD ARRHYTHMIA DETECTION SOFTWARE
Applicant
CARDIAC SCIENCE, INC.
1176 MAIN STREET, BLDG. C
IRVINE,  CA  92614
Applicant Contact STAN E TILLMAN
Correspondent
CARDIAC SCIENCE, INC.
1176 MAIN STREET, BLDG. C
IRVINE,  CA  92614
Correspondent Contact STAN E TILLMAN
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received08/04/1998
Decision Date 08/10/1998
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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