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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 K901280
Device Name DISPOSIBLE EEG NEEDLE ELECTRODES
Applicant
Medicotest, Inc.
One Metropolitan Sq.
211 N. Broadway, Suite 3600
St. Louis,  MO  63102
Applicant Contact JOHN I ALBER
Correspondent
Medicotest, Inc.
One Metropolitan Sq.
211 N. Broadway, Suite 3600
St. Louis,  MO  63102
Correspondent Contact JOHN I ALBER
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received03/19/1990
Decision Date 05/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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