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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K980148
Device Name NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR
Applicant
The Magstim Company , Ltd.
Spring Gardens, Whitland
Carmarthenshire,  GB SA34 OHR
Applicant Contact CHRIS HOVEY
Correspondent
The Magstim Company , Ltd.
Spring Gardens, Whitland
Carmarthenshire,  GB SA34 OHR
Correspondent Contact CHRIS HOVEY
Regulation Number874.1820
Classification Product Code
ETN  
Date Received01/15/1998
Decision Date 08/05/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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