EEG-acp

Media, Electroconductive

SOMNOmedics GmbH

The following data is part of a premarket notification filed by Somnomedics Gmbh with the FDA for Eeg-acp.

Pre-market Notification Details

Device IDK212325
510k NumberK212325
Device Name:EEG-acp
ClassificationMedia, Electroconductive
Applicant SOMNOmedics GmbH Am Sonnenstuhl 63 Randersacker,  DE 97236
ContactSabrina Forster
CorrespondentTimo Gehring
SOMNOmedics GmbH Am Sonnenstuhl 63 Randersacker,  DE 97236
Product CodeGYB  
CFR Regulation Number882.1275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-26
Decision Date2022-06-15

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