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510(k) Data Aggregation
K Number
K200496Device Name
Aer X
Manufacturer
Date Cleared
2020-07-24
(147 days)
Product Code
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
3B Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Aer X oxygen concentrator device is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Aer X may be used in home, institution, vehicle and various mobile environments.
Device Description
The Aer X oxygen concentrator utilies a molecular sieve and a differential pressure swing adsorption methodology to separate the gases in ambient air. The device takes the room air and concentrates the oxygen portion to produce a pulse of oxygen between 87-94% in purity. When the patient inhales, the device senses the pressure change and is triggered to release the oxygen pulse. In between breaths, the device regenerates an oxygen pulse and waits for the next inhalation breath before dispensing it
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