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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
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