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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Self-Fitting Air-Conduction Hearing Aid, Prescription
510(k) Number K223911
Device Name Lumen 155-SF
Applicant
Intricon Corporation
1260 Red Fox Rd.
Arden Hills,  MN  55112
Applicant Contact David Akbari
Correspondent
Intricon Corporation
1260 Red Fox Rd.
Arden Hills,  MN  55112
Correspondent Contact David Akbari
Regulation Number874.3325
Classification Product Code
QDD  
Subsequent Product Code
QUH  
Date Received12/29/2022
Decision Date 10/17/2023
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
Predetermined Change
Control Plan Authorized		 No
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