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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
DYFED, WALES,  GB SA34 OHR
Applicant Contact CHRIS HOVEY
Correspondent
THE MAGSTIM COMPANY LTD.
SPRING GARDENS, WHITLAND
DYFED, WALES,  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
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