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

    VENTILATOR MODEL BV-300 INFANT

    K Number: K790199 · Decision Apr 13, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    9
    Review Days
    77

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    Basic Information

    Device Name
    VENTILATOR MODEL BV-300 INFANT
    K Number
    K790199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bourns Medical Systems, Inc.
    Date Received
    January 26, 1979
    Decision Date
    April 13, 1979
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Bourns Medical Systems, Inc.

    K Number Device Name
    K802051 NEWBOURNS INFANT VENTILATOR
    K802118 BEAR 2 ADULT VOL. VENTILATOR
    K801697 MODEL BP-200 INFANT PRESSURE VENTILATOR
    K791186 MODEL BP-2000 TIME-CYCLED VENTILATOR
    K781760 HUMIDIFIERS, MODEL:LS-420 AND LS-460
    K781485 PATIENT CIRCUIT MANIFOLD
    K781515 MODEL LS-80 ADULT VENTILATION MONITOR
    K781428 FLEXTUBES:9, 20, 26