NeuroCap (Model DEC22)

Electrode, Cutaneous

Memory MD Inc

The following data is part of a premarket notification filed by Memory Md Inc with the FDA for Neurocap (model Dec22).

Pre-market Notification Details

Device IDK202913
510k NumberK202913
Device Name:NeuroCap (Model DEC22)
ClassificationElectrode, Cutaneous
Applicant Memory MD Inc 125 Wilbur Place, Suite 170 Bohemia,  NY  11171 6
ContactBoris Goldstein
CorrespondentMike Corcoran
Mtak LLC 8241 Enclave Cove Woodbury,  MN  55125
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-29
Decision Date2021-03-05

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