K Number
K253269
Device Name
OEC One CFD
Date Cleared
2025-11-26

(58 days)

Product Code
Regulation Number
892.1650
Reference & 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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