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510(k) Data Aggregation

    K Number
    K053063
    Device Name
    PRO-FLOW MULTIPURPOSE CANNULA
    Manufacturer
    PRO-TECH SERVICES, INC.
    Date Cleared
    2005-12-13

    (42 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PRO-FLOW MULTIPURPOSE CANNULA

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

    The Pro-Flow MultiPurpose Cannula may be intended for use for simultaneous detection of respiratory airflow and sampling, or delivery, of gases, such as EtC02 or oxygen.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for a medical device (Pro-Flow MultiPurpose Cannula), along with its indication for use. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the detailed study parameters requested in the prompt.

    Therefore, I cannot provide the requested information based on the input text. The document confirms that the device is substantially equivalent to a legally marketed predicate device but does not include any performance data or a description of a study.

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