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

    MANIFOLD KIT

    K Number: K780364 · Decision Mar 30, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    114
    Same Product Code
    54
    Applicant Total
    3
    Review Days
    24

    Basic Information

    Device Name
    MANIFOLD KIT
    K Number
    K780364
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2700
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    SPICA, INC.
    Date Received
    March 6, 1978
    Decision Date
    March 30, 1978
    Product Code
    CAN
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAN Regulator, Pressure, Gas Cylinder

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    Other Clearances by SPICA, INC.

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