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510(k) Data Aggregation

    K Number
    K974393
    Device Name
    VASO PRESS SYSTEM
    Manufacturer
    BRITT CORP., INC.
    Date Cleared
    1999-03-19

    (483 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Treatment of lymphatic and venous disorders.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Vaso Press System. It confirms that the device is substantially equivalent to a legally marketed predicate device for the treatment of lymphatic and venous disorders. The letter itself does not contain any information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or study designs (such as MRMC or standalone studies).

    Therefore, I cannot provide the requested information based on the text provided. This document is a regulatory approval, not a technical report detailing the performance studies.

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