Neon EEG

Electrode, Cutaneous

Incereb Ltd

The following data is part of a premarket notification filed by Incereb Ltd with the FDA for Neon Eeg.

Pre-market Notification Details

Device IDK151576
510k NumberK151576
Device Name:Neon EEG
ClassificationElectrode, Cutaneous
Applicant Incereb Ltd CENTRE OF APPLIED SCIENCE FOR HEALTH, INSTITUTE OF TECHNOLOGY TALLAGHT Dublin,  IE Dublin24
ContactPaul Phillips
CorrespondentPaul Phillips
INCEREB LTD CENTRE OF APPLIED SCIENCE FOR HEALTH, INSTITUTE OF TECHNOLOGY TALLAGHT Dublin,  IE Dublin24
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-11
Decision Date2015-09-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05391530950053 K151576 000
05391530950022 K151576 000
05391530950084 K151576 000
05391530950121 K151576 000
05391530950091 K151576 000

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