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510(k) K120397

MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM by Nihon Kohden Corp. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2012
Date Received
February 8, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

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