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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Nerve Conduction Velocity Measurement
510(k) Number K843924
Device Name DIGITAL ELECTRONEUROMETER S-100
Applicant
Neurotron, Inc.
P.O. Box 6480
Lawrenceville,  NJ  08648
Applicant Contact JACK GULDALIAN
Correspondent
Neurotron, Inc.
P.O. Box 6480
Lawrenceville,  NJ  08648
Correspondent Contact JACK GULDALIAN
Regulation Number882.1550
Classification Product Code
JXE  
Date Received10/05/1984
Decision Date 03/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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