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FDA 510(k) Application Details - K062331
Device Classification Name
Auxillary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.5300
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Classification Product Code
MPD
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More FDA Info for this Product Code
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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