K Number
K001624Device Name
GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04Manufacturer
Date Cleared
2001-01-25
(244 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
PMReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A