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510(k) Data Aggregation

    K Number
    K030374
    Device Name
    SONIK LDI 20 AIR
    Manufacturer
    EVIT LABS, INC.
    Date Cleared
    2003-08-25

    (202 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used to convert liquid medication into aerosol for inhalation by patient.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The provided text is an FDA 510(k) clearance letter for the Sonik LDI 20 Air Nebulizer, confirming its substantial equivalence to a predicate device.

    The letter discusses:

    • The device trade name and regulation number.
    • The FDA's determination of substantial equivalence.
    • Regulatory requirements and general controls for the device.
    • Contact information for further guidance.
    • An "Indications for Use" statement for the device.

    It does not include:

    • A table of acceptance criteria and reported device performance.
    • Details of a study conducted to demonstrate performance against specific criteria.
    • Information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
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