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510(k) Data Aggregation

    K Number
    K952267
    Device Name
    CRITERION, CRITERION I.V., MODIFIED
    Manufacturer
    NOVA-VENTRX
    Date Cleared
    1997-12-02

    (932 days)

    Product Code
    BZE
    Regulation Number
    868.5270
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    HYDRO-HEAT® Condensate Control System

    AI/ML Overview

    I'm sorry, but the provided text is a letter from the FDA regarding a 510(k) clearance for a device called the "HYDRO-HEAT® Condensate Control System." It discusses regulatory classifications, general controls, and compliance.

    However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other details you've requested about device performance and validation.

    Therefore, I cannot fulfill your request for this specific device based on the provided text.

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