K Number
K962292Device Name
HEARSAVERManufacturer
Date Cleared
1996-10-29
(137 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
ENReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A