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510(k) Data Aggregation
Device Name
DeVilbiss 5 Liter Oxygen Concentrator (555)Manufacturer
Date Cleared
2026-03-26
(132 days)
Product Code
Regulation Number
868.5440Type
TraditionalPanel
AnesthesiologyAge Range
18 - 999
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The DeVilbiss 5 Liter (555) Oxygen Concentrator is intended to provide supplemental oxygen to adult patients requiring oxygen therapy. The device may be used in the home or an institutional setting. The device is not intended to be life sustaining or life supporting.
Device Description
The DeVilbiss 5-Liter (555) Oxygen Concentrator (hereafter referred to as "555") is a portable device that produces an oxygen enriched gas mixture by drawing in room air and extracting nitrogen through a pressure swing adsorption process, allowing oxygen to be delivered at a range of prescribed flows to patients in need of supplemental oxygen.
AI/ML Overview
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