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510(k) Data Aggregation

    K Number
    K993307

    Validate with FDA (Live)

    Device Name
    ARIA LX CPAP SYSTEM
    Manufacturer
    RESPIRONICS, INC.
    Date Cleared
    1999-10-27

    (23 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Special
    Panel
    Anesthesiology
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K022192
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter. It states that marketing of the device is permitted but does not contain any information about acceptance criteria, device performance, study details, ground truth establishment, or sample sizes.

    Therefore, I cannot answer your request based on the input provided. The letter is a regulatory document confirming substantial equivalence, not a summary of the underlying technical and clinical studies.

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