510(k) K062331

HIGHPAK-12 by Ad Elektronik GmbH — Product Code MPD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2007
Date Received
August 10, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator
Device Class
Class II
Regulation Number
870.5300
Review Panel
CV
Submission Type