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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, vestibular analysis
510(k) Number K200529
Device Name Orion
Interacoustics A/S
Audiometer Alle 1
Middelfart,  DK DK-5500
Applicant Contact Erik Nielsen
lnteracoustics A/S
Audiometer Alle 1
Middelfart,  DK DK-5500
Correspondent Contact Erik Nielsen
Classification Product Code
Date Received03/02/2020
Decision Date 08/12/2020
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No