FDA 510(k) Application Details - K103783

Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)

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510(K) Number K103783
Device Name Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant FIAB S.P.A.
VIA COSTOLI, 4
VICCHIO FLORENCE 50039 IT
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Contact ALBERTO CALABRO
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Regulation Number 870.5300

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Classification Product Code LDD
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Date Received 12/27/2010
Decision Date 06/16/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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