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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Auditory, Evoked Response
510(k) Number K070696
Device Name INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)
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 Number882.1900
Classification Product Code
GWJ  
Date Received03/13/2007
Decision Date 06/29/2007
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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