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

    PRESSURE INFUSION DEVICE

    K Number: K781037 · Decision Sep 14, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    34
    Applicant Total
    1
    Review Days
    87

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    Basic Information

    Device Name
    PRESSURE INFUSION DEVICE
    K Number
    K781037
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5420
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Hinck Medical, Inc.
    Date Received
    June 19, 1978
    Decision Date
    September 14, 1978
    Product Code
    KZD
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZD Infusor, Pressure, For I.V. Bags

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