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

    HEMONIR TM

    K Number: K050014 · Decision May 5, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    122

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    Basic Information

    Device Name
    HEMONIR TM
    K Number
    K050014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nir Diagnostics, Inc.
    Date Received
    January 3, 2005
    Decision Date
    May 5, 2005
    Product Code
    GLY
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GLY Oximeter To Measure Hemoglobin

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