K Number
K010989Manufacturer
Date Cleared
2001-11-07
(218 days)
Product Code
Regulation Number
888.3060Type
TraditionalPanel
OrthopedicReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A