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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Photic, Evoked Response
510(k) Number K831651
Device Name EVOKED POTENTIAL SYSTEM 2000
Applicant
Ophthalmetric Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Ophthalmetric Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number882.1890
Classification Product Code
GWE  
Date Received05/23/1983
Decision Date 09/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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