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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 K200759
Device Name NIM Vital, Nerve Integrity Monitor
Applicant
Medtronic Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216 -0980
Applicant Contact Marek Pawlowski
Correspondent
Medtronic Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216 -0980
Correspondent Contact Marek Pawlowski
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Code
ETN  
Date Received03/24/2020
Decision Date 10/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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