SAC2 - Electrode Cream

Media, Electroconductive

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 Sac2 - Electrode Cream.

Pre-market Notification Details

Device IDK192606
510k NumberK192606
Device Name:SAC2 - Electrode Cream
ClassificationMedia, Electroconductive
Applicant Spes Medica S.r.l. Via Europa - Zona Industriale Battipaglia (sa),  IT 84091
ContactGiogio Facco
CorrespondentGiorgio Facco
Spes Medica S.r.l. Via Europa - Zona Industriale Battipaglia (sa),  IT 84091
Product CodeGYB  
CFR Regulation Number882.1275 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-20
Decision Date2020-01-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18054655027157 K192606 000

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