K Number
K000418Device Name
PDT DOSECALCULATOR, MODEL 80000Manufacturer
Date Cleared
2000-10-24
(259 days)
Product Code
Regulation Number
868.1890Type
TraditionalPanel
HOReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).