K Number
K963233Device Name
EZ-SCREEN PROFILEManufacturer
Date Cleared
1996-10-31
(73 days)
Regulation Number
N/AType
TraditionalPanel
TXReference & 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