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510(k) Data Aggregation

    K Number
    K982910
    Device Name
    HAMILTON MEDICAL GALILEOVENTILATOR
    Manufacturer
    HAMILTON MEDICAL, INC.
    Date Cleared
    1999-09-14

    (392 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HAMILTON MEDICAL GALILEOVENTILATOR

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

    The Galileo Ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients. The Galileo ventilator is intended for use where patient care is provided in the hospital and institutional environment. It is not intended for transport outside by health care professional environment or for home use.

    Device Description

    Not Found

    AI/ML Overview

    This document does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a letter from the FDA to Hamilton Medical, Inc. regarding the 510(k) premarket notification for the Hamilton Medical Galileo Ventilator.

    The letter states that the device has been found substantially equivalent to legally marketed predicate devices and outlines the regulatory framework for marketing the device. It also includes an "Indications for Use" statement for the Galileo Ventilator.

    Therefore, I cannot provide the requested information based on the input text.

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