BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HEMOBAND, MODELS HB-NS AND HB-NSXL

    K Number: K081740 · Decision Mar 12, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    181
    Applicant Total
    1
    Review Days
    266

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    Basic Information

    Device Name
    HEMOBAND, MODELS HB-NS AND HB-NSXL
    K Number
    K081740
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Innovations For Access, Inc.
    Date Received
    June 19, 2008
    Decision Date
    March 12, 2009
    Product Code
    KOC
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KOC Accessories, Blood Circuit, Hemodialysis

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