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510(k) Data Aggregation

    K Number
    K983627
    Device Name
    VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM
    Manufacturer
    INVACARE CORP.
    Date Cleared
    1999-10-22

    (372 days)

    Product Code
    CAW,DAT
    Regulation Number
    868.5440
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is indicated for supplemental Medical Oxygen for treatment of Respiratory Diseases.

    Device Description

    Invacare Venture Home Fill Complete Oxygen System

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Invacare Model IHO 100 Home Fill Complete Home Oxygen System." This type of document declares substantial equivalence to a predicate device and permits marketing. It does not contain any information about acceptance criteria, device performance studies, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the given input. The document is strictly a regulatory clearance letter and does not delve into the technical details of the device's performance or the studies conducted to demonstrate it.

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