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510(k) Data Aggregation

    K Number
    K020324
    Device Name
    LIFESTYLE OXYGEN CONCENTRATOR
    Manufacturer
    AIRSEP CORP.
    Date Cleared
    2002-03-13

    (41 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LIFESTYLE OXYGEN CONCENTRATOR

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

    The portable AirSep LifeStyle Oxygen Concentrator is intended to provide supplemental, high-purity oxygen in a home, institutional, or travel environment.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested regarding acceptance criteria and a study that proves a device meets those criteria. The text is a letter from the FDA to Airsep Corp. regarding the 510(k) premarket notification for the LifeStyle Oxygen Concentrator. It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements. It does not include details about device performance, study methodologies, sample sizes, expert qualifications, or ground truth establishment.

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