K Number
K000808Manufacturer
Date Cleared
2000-08-25
(165 days)
Regulation Number
890.5850Type
TraditionalPanel
Physical MedicineReference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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N/A