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510(k) Data Aggregation

    K Number
    K251607

    Validate with FDA (Live)

    Date Cleared
    2025-11-21

    (178 days)

    Product Code
    Regulation Number
    868.5440
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Oxygen Concentrator provides supplemental low flow oxygen therapy for adult in the home, nursing homes, patient care facilities, etc. It is available by prescription only under the supervision of a physician, and it's not intended to support or sustain life.

    Device Description

    The Oxygen Concentrator is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce oxygen. The device can separate nitrogen by absorbing through the molecular sieve when the room air enters the device and allows the enriched oxygen to be collected. The device could provide approximately 90~96% of oxygen to patients on a continuous flow basis at a rate of 1L/min to 5L/min. The nasal cannula is not sold with the device, users need to purchase accessories by themselves that are legally marketed. The products have not undergone biocompatibility assessment of condensate precipitates according to ISO18562-4.
    The maximum altitude the subject device can operate without degradation of concentration is 2000m.

    AI/ML Overview

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