FDA 510(k) Application Details - K062331

Device Classification Name Auxillary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator

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510(K) Number K062331
Device Name Auxillary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
Applicant AD ELEKTRONIK GMBH
3924 CASCADE BEACH ROAD
LUTSEN, MN 55612-9532 US
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Contact GREGORY J MATHISON
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Regulation Number 870.5300

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Classification Product Code MPD
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Date Received 08/10/2006
Decision Date 07/10/2007
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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