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510(k) K963195

WIRELESS EEG RECORDING SYSTEM MODEL W32 by Cme Telemetrix, Inc. — Product Code GYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1997
Date Received
August 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Encephalogram Telemetry System
Device Class
Class II
Regulation Number
882.1855
Review Panel
NE
Submission Type

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