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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K170677
Device Name Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
Applicant
Neurovision Medical Product, Inc.
353 Sanjon Rd.
Ventura,  CA  93001
Applicant Contact Christine Vergely
Correspondent
Neurovision Medical Product, Inc.
353 Sanjon Rd.
Ventura,  CA  93001
Correspondent Contact Christine Vergely
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Code
ETN  
Date Received03/06/2017
Decision Date 04/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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