K Number
DEN210033Device Name
Lenire Tinnitus Treatment DeviceManufacturer
Date Cleared
2023-03-06
(565 days)
Product Code
Regulation Number
874.3410Type
DirectPanel
ENReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A