LARYNGEAL ELECTRODE

Stimulator, Nerve

TECHNOMED EUROPE

The following data is part of a premarket notification filed by Technomed Europe with the FDA for Laryngeal Electrode.

Pre-market Notification Details

Device IDK121257
510k NumberK121257
Device Name:LARYNGEAL ELECTRODE
ClassificationStimulator, Nerve
Applicant TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport,  NL 6199 Ae
ContactPierre Vreuls
CorrespondentPierre Vreuls
TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport,  NL 6199 Ae
Product CodeETN  
CFR Regulation Number874.1820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-26
Decision Date2012-08-28
Summary:summary

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