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510(k) Data Aggregation

    K Number
    K243833
    Date Cleared
    2025-09-29

    (290 days)

    Product Code
    Regulation Number
    868.5440
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K242736, K111885

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Oxygen Concentrator 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 Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment (not include emergency medical services environment). The oxygen concentrator for adult use, providing pulsed oxygen flow.

    Device Description

    Portable Oxygen Concentrator, model: JAY-1000P is a portable oxygen generator that is intended to release oxygen for respiratory therapy by means of physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The JAY-1000P is small, portable and may be used in home, institutional, or travel environment.

    The portable oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, battery, solenoid valve, molecular sieve, circuit control system, heat dissipation system, and a flow control device. Accessories include power adapters.

    AI/ML Overview

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