MARQUETTE DEFIB ELECTRODES

Automated External Defibrillators (non-wearable)

MARQUETTE ELECTRONICS, INC.

The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Marquette Defib Electrodes.

Pre-market Notification Details

Device IDK952101
510k NumberK952101
Device Name:MARQUETTE DEFIB ELECTRODES
ClassificationAutomated External Defibrillators (non-wearable)
Applicant MARQUETTE ELECTRONICS, INC. 100 MARQUETTE DR. Jupiter,  FL  33468
ContactMichael T Laughran
CorrespondentMichael T Laughran
MARQUETTE ELECTRONICS, INC. 100 MARQUETTE DR. Jupiter,  FL  33468
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-04
Decision Date1995-09-07

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