BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VERSION OF A CLOSED-FLOW SYS. CALORIC

    K Number: K813490 · Decision Jan 7, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    34

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    Basic Information

    Device Name
    VERSION OF A CLOSED-FLOW SYS. CALORIC
    K Number
    K813490
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.5300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Thomas M. Foti, M.D.
    Date Received
    December 4, 1981
    Decision Date
    January 7, 1982
    Product Code
    ETF
    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
    ETF Unit, Examining/Treatment, Ent

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