MINIDEF (OR DEFIPORT

Dc-defibrillator, Low-energy, (including Paddles)

ODAM

The following data is part of a premarket notification filed by Odam with the FDA for Minidef (or Defiport.

Pre-market Notification Details

Device IDK823933
510k NumberK823933
Device Name:MINIDEF (OR DEFIPORT
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant ODAM SIEGE SOCIAL 67160 WISSEMBOURG FRANCE ,  FR
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-29
Decision Date1983-04-12

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