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

    HORTMANN AIRMATIC AIR CALORIC STIMULATOR

    K Number: K950785 · Decision Jun 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    6
    Applicant Total
    92
    Review Days
    127

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    Basic Information

    Device Name
    HORTMANN AIRMATIC AIR CALORIC STIMULATOR
    K Number
    K950785
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.1800
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jedmed Instrument Co.
    Date Received
    February 21, 1995
    Decision Date
    June 28, 1995
    Product Code
    KHH
    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
    KHH Stimulator, Caloric-Air

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