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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 K803226
Device Name EVOKED RESPONSE STIMULATORS
Applicant
BIO-LOGIC SYSTEMS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIO-LOGIC SYSTEMS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1845
Classification Product Code
GWK  
Date Received12/19/1980
Decision Date 02/05/1981
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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