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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Amplifier, Physiological Signal
510(k) Number K821250
Device Name METRACO EVOKED POTENTIAL SYSTEM
Applicant
METRACO, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
METRACO, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1835
Classification Product Code
GWL  
Date Received04/30/1982
Decision Date 07/02/1982
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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