K Number
K954411Device Name
GALVA-5-MManufacturer
Date Cleared
1996-02-28
(160 days)
Product Code
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