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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Nerve Locator
510(k) Number K181559
Device Name Neurosign V4 Intraoperative Nerve Monitor
Applicant
Magstim Company, Ltd.
Spring Gardens
Whitland,  GB SA340HR
Applicant Contact Tom Campbell
Correspondent
Magstim Company, Ltd.
Spring Gardens
Whitland,  GB SA340HR
Correspondent Contact Tom Campbell
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Code
ETN  
Date Received06/13/2018
Decision Date 11/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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