LINE POWERED LOW ENERGY DEFIBRILLATOR II

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

NARCO SCIENTIFIC

The following data is part of a premarket notification filed by Narco Scientific with the FDA for Line Powered Low Energy Defibrillator Ii.

Pre-market Notification Details

Device IDK813471
510k NumberK813471
Device Name:LINE POWERED LOW ENERGY DEFIBRILLATOR II
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant NARCO SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-12-14
Decision Date1981-12-29

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