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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Vibration Threshold Measurement
510(k) Number K853608
Device Name NEUROMETER
Applicant
Neurotron, Inc.
6211 Falls Rd.
Baltimore,  MD  21209
Applicant Contact JEFFERSON KATIMS
Correspondent
Neurotron, Inc.
6211 Falls Rd.
Baltimore,  MD  21209
Correspondent Contact JEFFERSON KATIMS
Regulation Number882.1200
Classification Product Code
LLN  
Date Received08/28/1985
Decision Date 06/12/1986
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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