CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON

Electrode, Cortical

RADIONICS, INC.

The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Cortical Surf Epilepsy Elect Depth Elec Epilep Mon.

Pre-market Notification Details

Device IDK926424
510k NumberK926424
Device Name:CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON
ClassificationElectrode, Cortical
Applicant RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington,  MA  01803 -0738
ContactLinda Jalbert
CorrespondentLinda Jalbert
RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington,  MA  01803 -0738
Product CodeGYC  
CFR Regulation Number882.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-23
Decision Date1993-11-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M272AU8D5L251 K926424 000
M272AU12D5L251 K926424 000
M272AU4D10L251 K926424 000
M272AU4D10L51 K926424 000
M272AU4D5L251 K926424 000
M272AU6D10L251 K926424 000
M272AU6D10L51 K926424 000
M272AU6D5L251 K926424 000
M272AU8D10L251 K926424 000
M272AU8D10L51 K926424 000
M272AU10D5L251 K926424 000

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