510(k) K103783

EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC by Fiab Spa — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2011
Date Received
December 27, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device Class
Class II
Regulation Number
870.5300
Review Panel
CV
Submission Type