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510(k) Data Aggregation

    K Number
    K984085
    Device Name
    RITEFLO SPACER
    Manufacturer
    AEROMAX TECHNOLOGIES, INC.
    Date Cleared
    1999-08-05

    (262 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

    The Intelliflo Spacer is intended to be used in combination with Metered Dose Inhaler's (MDI) to assist in respiratory steroid drug delivery. The target population includes all patients using MDI's i.e., children, elderly, and adults.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "Intelliflo Spacer." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    However, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about a standalone algorithm study or an MRMC comparative effectiveness study.

    The letter only provides:

    • Device Name: Intelliflo Spacer
    • Regulatory Class: II
    • Product Code: CAF
    • Indications for Use: "The Intelliflo Spacer is intended to be used in combination with Metered Dose Inhaler's (MDI) to assist in respiratory steroid drug delivery. The target population includes all patients using MDI's i.e., children, elderly, and adults."

    Therefore, I cannot provide the requested table and study details based solely on the input provided. The document is a clearance letter, not a study report or a summary of performance data.

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