K Number
DEN240023Device Name
SmartFlow Neuro CannulaManufacturer
Date Cleared
2024-11-13
(175 days)
Product Code
Regulation Number
882.4110Type
DirectPanel
NEReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A