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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 K910624
Device Name CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4
Applicant
WR MEDICAL ELECTRONICS CO.
123 NO.2ND.STREET
STILLWATER,  MN  55082
Applicant Contact PAUL J ANDERSON
Correspondent
WR MEDICAL ELECTRONICS CO.
123 NO.2ND.STREET
STILLWATER,  MN  55082
Correspondent Contact PAUL J ANDERSON
Regulation Number882.1200
Classification Product Code
LLN  
Date Received02/12/1991
Decision Date 01/17/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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