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

    HUMIDIFIERS, MODEL:LS-420 AND LS-460

    K Number: K781760 · Decision Dec 20, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    9
    Review Days
    65

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    Basic Information

    Device Name
    HUMIDIFIERS, MODEL:LS-420 AND LS-460
    K Number
    K781760
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bourns Medical Systems, Inc.
    Date Received
    October 16, 1978
    Decision Date
    December 20, 1978
    Product Code
    BTT
    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
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

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    Other Clearances by Bourns Medical Systems, Inc.

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    K791186 MODEL BP-2000 TIME-CYCLED VENTILATOR
    K790199 VENTILATOR MODEL BV-300 INFANT
    K781485 PATIENT CIRCUIT MANIFOLD
    K781515 MODEL LS-80 ADULT VENTILATION MONITOR
    K781428 FLEXTUBES:9, 20, 26