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

    DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR

    K Number: K830090 · Decision Feb 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    27
    Applicant Total
    33
    Review Days
    27

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    Basic Information

    Device Name
    DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR
    K Number
    K830090
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5070
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Hudson Oxygen Therapy Sales Co.
    Date Received
    January 11, 1983
    Decision Date
    February 7, 1983
    Product Code
    JXL
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JXL Block, Bite

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