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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conditioner, Signal, Physiological
510(k) Number K771742
Device Name EVOKED RESPONSE SYS., MODEL 10
Applicant
Grass Instrument Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Grass Instrument Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number882.1845
Classification Product Code
GWK  
Date Received09/15/1977
Decision Date 11/22/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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