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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 K240430
Device Name Otoport Pro
Applicant
Otodynamics, Ltd.
30-38 Beaconsfield Rd.
Hatfield, Hertfordshire,  GB AL10-8BB
Applicant Contact Daniel Budd
Correspondent
Rook Quality Systems
1155 Mount Vernon Hwy. #800
Dunwoody,  GA  30338
Correspondent Contact Chandler Thames
Regulation Number874.1050
Classification Product Code
EWO  
Subsequent Product Code
GWJ  
Date Received02/14/2024
Decision Date 03/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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