K Number
DEN250002Device Name
Delphi-MD SystemManufacturer
Date Cleared
2025-08-20
(229 days)
Product Code
Regulation Number
882.1860Type
DirectPanel
NeurologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A