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510(k) K841497

NEUROPACK 8 MEE 4108 by Nihon Kohden America, Inc. — Product Code GWK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1984
Date Received
April 10, 1984
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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