VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM


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

Correspodent Contact daniel eggan
Regulation Number 882.1460
Classification Product Code
GWN  
Date Received 08/14/2007
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