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510(k) K905594

NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 by Nihon Kohden America, Inc. — Product Code GWK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1991
Date Received
December 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conditioner, Signal, Physiological
Device Class
Class II
Regulation Number
882.1845
Review Panel
NE
Submission Type

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