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

    SIMVAC

    K Number: K811991 · Decision Aug 12, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    30

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    Basic Information

    Device Name
    SIMVAC
    K Number
    K811991
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5955
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    The Lynn Terrell Co.
    Date Received
    July 13, 1981
    Decision Date
    August 12, 1981
    Product Code
    CBO
    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
    CBO Attachment, Intermittent Mandatory Ventilation (Imv)

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