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

    CONTROLLER, SERVO, INSPIRON

    K Number: K780630 · Decision May 31, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    645
    Review Days
    44

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    Basic Information

    Device Name
    CONTROLLER, SERVO, INSPIRON
    K Number
    K780630
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5270
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    C.R. Bard, Inc.
    Date Received
    April 17, 1978
    Decision Date
    May 31, 1978
    Product Code
    BZE
    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
    BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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