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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 K883914
Device Name FATIGMETER
Applicant
K. Jimbo Co., Inc.
6363 Wilshire Blvd., Suite
406
Los Angeles,  CA  90048
Applicant Contact BRUCE L BIRCHARD
Correspondent
K. Jimbo Co., Inc.
6363 Wilshire Blvd., Suite
406
Los Angeles,  CA  90048
Correspondent Contact BRUCE L BIRCHARD
Regulation Number882.1890
Classification Product Code
GWE  
Date Received09/16/1988
Decision Date 10/31/1989
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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