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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 Drive North
Jacksonville,  FL  32216 -0980
Applicant Contact Marek Pawlowski
Correspondent
Medtronic Xomed, Inc.
6743 Southpoint Drive North
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
Recalls CDRH Recalls
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