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

    HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL

    K Number: DEN050007 · Decision Mar 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    280

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    Basic Information

    Device Name
    HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL
    K Number
    DEN050007
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    874.1600
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Unknown
    Applicant
    Fmg Innovations, Inc.
    Date Received
    June 20, 2005
    Decision Date
    March 27, 2006
    Product Code
    NRK
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NRK Kit, Test, Olfactory