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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 K833413
Device Name COMPUTERSCOPE CPS-ABR
Applicant
RC ELECTRONICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RC ELECTRONICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1835
Classification Product Code
GWL  
Date Received09/30/1983
Decision Date 11/28/1983
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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