DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES

Electrode, Cutaneous

TECHNOMED EUROPE

The following data is part of a premarket notification filed by Technomed Europe with the FDA for Disposable Adhesive Surface Electrodes, Disc Electrodes.

Pre-market Notification Details

Device IDK073532
510k NumberK073532
Device Name:DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
ClassificationElectrode, Cutaneous
Applicant TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport,  NL 6199 Ae
ContactMaurice Roost
CorrespondentMaurice Roost
TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport,  NL 6199 Ae
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-17
Decision Date2008-05-01
Summary:summary

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