DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED

Electrode, Needle, Diagnostic Electromyograph

TECHNOMED EUROPE

The following data is part of a premarket notification filed by Technomed Europe with the FDA for Disposable Hypodermic Emg Needle Electrode Technomed Europe Version And Private Labeled.

Pre-market Notification Details

Device IDK062437
510k NumberK062437
Device Name:DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED
ClassificationElectrode, Needle, Diagnostic Electromyograph
Applicant TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport,  NL 6199 Ae
ContactRene Roncken
CorrespondentRene Roncken
TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport,  NL 6199 Ae
Product CodeIKT  
CFR Regulation Number890.1385 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-11
Decision Date2007-02-16
Summary:summary

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