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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Encephalogram Telemetry System
510(k) Number K963195
Device Name WIRELESS EEG RECORDING SYSTEM MODEL W32
Applicant
CME TELEMETRIX, INC.
1129 BLOOMFIELD AVE.
WEST CALDWELL,  NJ  07006
Applicant Contact ANNE MARIE CESARIO
Correspondent
CME TELEMETRIX, INC.
1129 BLOOMFIELD AVE.
WEST CALDWELL,  NJ  07006
Correspondent Contact ANNE MARIE CESARIO
Regulation Number882.1855
Classification Product Code
GYE  
Date Received08/15/1996
Decision Date 07/29/1997
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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