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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cortical
510(k) Number K961942
Device Name EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI
Applicant
Radionics, Inc.
P.O. Box 438
22 Terry Ave.
Burlington,  MA  01803
Applicant Contact AMY J LAFORTE
Correspondent
Radionics, Inc.
P.O. Box 438
22 Terry Ave.
Burlington,  MA  01803
Correspondent Contact AMY J LAFORTE
Regulation Number882.1310
Classification Product Code
GYC  
Subsequent Product Code
GZL  
Date Received05/20/1996
Decision Date 08/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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