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510(k) Data Aggregation

    K Number
    K990429
    Device Name
    MODIFICATION OF VENTURI VENTILATOR
    Manufacturer
    CARDIOPULMONARY CORP.
    Date Cleared
    1999-02-24

    (13 days)

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

    MODIFICATION OF VENTURI VENTILATOR

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

    The Venturi® ventilator is intended to mechanically control or assist the breathing of adult and pediatric patients. The Venturi® is designed for use in hospital intensive care units (ICU).

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria, study details, or performance data for the Venturi® Ventilator. The document is an FDA 510(k) clearance letter from 1999, which primarily states that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use.

    Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them.

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