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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 K991642
FOIA Releasable 510(k) K991642
Device Name EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX
Applicant
Bertec Corp.
6185 Huntley Rd., Suite B
Columbus,  OH  43229
Applicant Contact DOUG MORR
Correspondent
Bertec Corp.
6185 Huntley Rd., Suite B
Columbus,  OH  43229
Correspondent Contact DOUG MORR
Regulation Number882.1460
Classification Product Code
GWN  
Date Received05/13/1999
Decision Date 08/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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