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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 K945799
Device Name NEUROSIGN 100 IMPEDANCE METER
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 Received11/28/1994
Decision Date 06/02/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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