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510(k) Data Aggregation

    K Number
    K013297
    Date Cleared
    2002-06-14

    (254 days)

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

    To apply compression to the lower limbs to help prevent deep vein thrombosis in patients at risk.

    Device Description

    MRSI Compressible Limb Sleeve

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "MRSI Compressible Limb Sleeve." It primarily addresses the regulatory approval of the device and does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot fulfill your request for the detailed information as described in your prompt from the provided text. The document focuses on regulatory equivalence to a predicate device rather than performance metrics from a specific study.

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