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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K234095
Device Name OtoNova/OtoNova Pro
Applicant
Otodynamics
30-38 Beaconsfield Rd
Hatfield, Hertfordshire,  GB AL10 8BB
Applicant Contact Daniel Budd
Correspondent
Rook Quality Systems
1155 Mount Vernon Hwy
Suite 800
Dunwoody,  GA  30338
Correspondent Contact Chandler Thames
Regulation Number874.1050
Classification Product Code
EWO  
Subsequent Product Code
GWJ  
Date Received12/26/2023
Decision Date 06/21/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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