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510(k) Data Aggregation

    K Number
    K031128
    Device Name
    B-SMART, MODEL B-01
    Manufacturer
    MACOSTA MEDICAL USA, LLC
    Date Cleared
    2004-01-15

    (281 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MACOSTA MEDICAL USA, LLC

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

    The Macosta Medical B-Smart Nerve Block Injection Pressure Manometer is a device for measuring injection pressure during administration of peripheral nerve blocks.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "B-Smart Nerve Block Injection Pressure Manometer." It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided document does not contain the information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. These details are typically found in the 510(k) summary or other supporting documentation submitted to the FDA, not in the clearance letter itself.

    Therefore, I cannot provide the requested information based on the text provided.

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