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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 K010981
Device Name GSA GENITO SENSORY ANALYZER
Applicant
MEDOC LTD. ADVANCED MEDICAL SYSTEMS
11660 WAYZATA BLVD.
MINNETONKA,  MN  55305
Applicant Contact ANN QUINLAN-SMITH
Correspondent
MEDOC LTD. ADVANCED MEDICAL SYSTEMS
11660 WAYZATA BLVD.
MINNETONKA,  MN  55305
Correspondent Contact ANN QUINLAN-SMITH
Regulation Number882.1200
Classification Product Code
LLN  
Date Received04/02/2001
Decision Date 09/20/2001
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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