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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 K972243
Device Name 2D VOG - VIDEO-OCULOGRAPHY
Applicant
Sensomotoric Instruments, GmbH
Potsdamer St. 18a
Teltow,  DE 14513
Applicant Contact ANNIKKI PERSSON
Correspondent
Sensomotoric Instruments, GmbH
Potsdamer St. 18a
Teltow,  DE 14513
Correspondent Contact ANNIKKI PERSSON
Regulation Number882.1460
Classification Product Code
GWN  
Date Received06/16/1997
Decision Date 09/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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