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FDA 510(k) Application Details - K964991
Device Classification Name
Automated External Defibrillators (Non-Wearable)
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510(K) Number
K964991
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
CARDIOTRONICS SYSTEMS, INC.
5966 LA PLACE CT.
CARLSBAD, CA 92008 US
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Contact
TIM J WAY
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Regulation Number
870.5310
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Classification Product Code
MKJ
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More FDA Info for this Product Code
Date Received
12/13/1996
Decision Date
01/15/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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