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510(k) Data Aggregation

    K Number
    K081740
    Device Name
    HEMOBAND, MODELS HB-NS AND HB-NSXL
    Manufacturer
    INNOVATIONS FOR ACCESS, INC.
    Date Cleared
    2009-03-12

    (266 days)

    Product Code
    KOC
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATIONS FOR ACCESS, INC.

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

    The HemoBand is used to provide pressure hemostasis of arterial, venous and dialysis access needle puncture sites.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device. The document is a 510(k) clearance letter from the FDA to Hemoband Corporation for their HemoBand devices, stating substantial equivalence to predicate devices and outlining regulatory requirements. It does not contain the kind of detailed study information requested.

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