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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
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