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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 K863607
Device Name VIBRATRON II, VIBRATION SENSITIVITY TESTER
Applicant
Sensortek, Inc.
154 Huron Ave.
Clifton,  NJ  07013
Applicant Contact RONALD R FELLER
Correspondent
Sensortek, Inc.
154 Huron Ave.
Clifton,  NJ  07013
Correspondent Contact RONALD R FELLER
Regulation Number882.1200
Classification Product Code
LLN  
Date Received09/16/1986
Decision Date 12/03/1986
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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