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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 K072254
Device Name VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
Applicant
INTERACOUSTICS A/S
7625 GOLDEN TRIANGLE DRIVE
EDEN PRAIRIE,  MN  55344
Applicant Contact DANIEL EGGAN
Correspondent
INTERACOUSTICS A/S
7625 GOLDEN TRIANGLE DRIVE
EDEN PRAIRIE,  MN  55344
Correspondent Contact DANIEL EGGAN
Regulation Number882.1460
Classification Product Code
GWN  
Date Received08/14/2007
Decision Date 02/05/2008
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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