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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K020910
Device Name SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
Applicant
THE ELECTRODE STORE, INC.
936-11TH AVENUE EAST
SEATTLE,  WA  98102
Applicant Contact CARL YOUNGMANN
Correspondent
THE ELECTRODE STORE, INC.
936-11TH AVENUE EAST
SEATTLE,  WA  98102
Correspondent Contact CARL YOUNGMANN
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received03/20/2002
Decision Date 07/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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