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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 K843486
Device Name VIBRAMETER
Applicant
Somedic AB
Box 14162
S-104 41 Stockholm
Sweden, 
Applicant Contact BO G JOHANSSON
Correspondent
Somedic AB
Box 14162
S-104 41 Stockholm
Sweden, 
Correspondent Contact BO G JOHANSSON
Regulation Number882.1200
Classification Product Code
LLN  
Date Received09/06/1984
Decision Date 12/24/1984
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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