K Number
K251957Device Name
Coaptium Connect with Tissium LightManufacturer
Date Cleared
2025-09-08
(75 days)
Product Code
Regulation Number
882.5270Type
SpecialPanel
NEReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A