Spes Medica Subdermal Needle Electrodes

Electrode, Needle

Spes Medica S.r.l.

The following data is part of a premarket notification filed by Spes Medica S.r.l. with the FDA for Spes Medica Subdermal Needle Electrodes.

Pre-market Notification Details

Device IDK192603
501k NumberK192603
Device Name:Spes Medica Subdermal Needle Electrodes
ClassificationElectrode, Needle
Applicant Spes Medica S.r.l. Via Europa - Zona Industriale Battipaglia (sa),  IT 84091
ContactGiorgio Facco
CorrespondentGiorgio Facco
Spes Medica S.r.l. Via Europa - Zona Industriale Battipaglia (sa),  IT 84091
Product CodeGXZ  
CFR Regulation Number882.1350 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
501k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-20
Decision Date2019-11-22

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