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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nystagmograph
510(k) Number K863424
Device Name COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE
Applicant
MICROMEDICAL TECHNOLOGIES, INC.
RR BOX 176-1
RTES 4 AND 104
AUBURN,  IL  62615
Applicant Contact RICHARD D MILES,PHD
Correspondent
MICROMEDICAL TECHNOLOGIES, INC.
RR BOX 176-1
RTES 4 AND 104
AUBURN,  IL  62615
Correspondent Contact RICHARD D MILES,PHD
Regulation Number882.1460
Classification Product Code
GWN  
Date Received09/04/1986
Decision Date 03/23/1987
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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