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

    IMV MANIFOLDS

    K Number: K811908 · Decision Jul 16, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    14
    Applicant Total
    76
    Review Days
    15

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    Basic Information

    Device Name
    IMV MANIFOLDS
    K Number
    K811908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5955
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Airlife, Inc.
    Date Received
    July 1, 1981
    Decision Date
    July 16, 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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    K832725 DUAL DIAL VENTURI STYLE MASK
    K831246 WHISTLER IN-LINE PRESSURE RELEASE VALVE
    K830895 SINGLE USE NEBULIZER, ADJUST. AIR-
    K830896 HUMIDIFIER, WITH OR WITHOUT ADAPTER
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