K Number
DEN240066Device Name
COAPTIUM Connect with TISSIUM LIGHTManufacturer
Date Cleared
2025-06-17
(208 days)
Product Code
Regulation Number
N/AType
DirectPanel
NEReference & 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