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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 K242198
Device Name ICS Dizcovery (1091)
Applicant
Natus Medical Denmark Aps
Hoerskaetten 9
Taastrup,  DK DK-2630
Applicant Contact Therese Coffey
Correspondent
Natus Medical Denmark Aps
Hoerskaetten 9
Taastrup,  DK DK-2630
Correspondent Contact Therese Coffey
Regulation Number882.1460
Classification Product Code
GWN  
Date Received07/26/2024
Decision Date 02/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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