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510(k) Data Aggregation

    K Number
    K992788
    Device Name
    BEAR CUB 750 PSV
    Manufacturer
    BEAR MEDICAL SYSTEMS, INC.
    Date Cleared
    1999-09-16

    (28 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEAR MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BEAR CUB 750 PSV Infant Ventilator is intended to provide clinically accepted features for the ventilation management of a patient population ranging from the small neonate (500 grams and larger) to a small pediatric patient (up to 30 kilograms). The etiologies to which these devices may be applied consistent with current clinical practices include: - Hyaline Membrane Disease Respiratory Distress Syndrome Low Surfactant Syndrome Chronic Lung Disease of the Neonate/Pediatric Patient Neurological Impairment Pulmonary Hypoplasia Persistent Pulmonary Hypertension Meconium Aspiration
    Device Description
    The BEAR CUB 750 PSV Infant ventilators is a modification from the BEAR CUB 750 vs. The BEAR CUB 750 PSV Infant ventilators incorporate all previous (3) three modes with the addition of (4) four new modes. The additional modes are, Flow Cycle Assist Control, Flow Cycle SIMV, SIMVPSV, and PSV. The BEAR CUB 750 PSV Infant ventilators incorporate all previous function for the Bear Cub 750vs with the addition of, digital PEEP, monitored inspired tidal volume, a low minute volume alarm, an audible silence for the volume limit, CPAP/PSV back up function and the Low Inspiratory Pressure threshold was changed to a calculated threshold function.
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    K Number
    K983981
    Device Name
    BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE
    Manufacturer
    BEAR MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-11-20

    (11 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEAR MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BEAR® 1000 Ventilator is fully capable of ventilating the entire spectrum of patients requiring such support-from the Emergency Room to the ICU, from pediatric patients to adults.
    Device Description
    The BEAR® 1000 Ventilator employs both microprocessor and microcontroller technology to vield a simple, compact design. This full-featured package has powerful performance capabilities-in terms of output capability, Sensitivity to patient demand and response time. They render the BEAR® 1000 Ventilator fully capable of ventilating the entire spectrum of patients requiring such support-from the Emergency Room to the ICU, from pediatric patients to adults. The modifications to the Bear 1000 % Ventilator are minor, and primarily affect only the monitoring capabilities of the system, with the exception of the addition of one alarm. There is no impact to the control functions of the ventilator. These modifications are: The addition of esophageal and tracheal pressure monitoring. All monitoring is the result of pressure data that is obtained through the esophageal and tracheal catheters and communicated to the Graphic Display via the RS-232 communication port. The addition of one alarm -- Prolonged Esophageal Pressure. The addition of one membrane key switch for filling the esophageal catheter balloon with air. The addition of a bi-directional flow sensor at the patient wve using a presently approved and marketed technology to enhance the flow and volume monitoring capabilities. The bidirectional flow sensor measures inspiratory and expiratory flow that is used in calculating and displaying digital data and various waveforms/loops on the Graphic Display. The user has the option of using either the bi-directional flow sensor or the exhaled flow sensor. The digital data calculated by and displayed on the Graphic Display has been enhanced to include 17 additional respiratory parameters which are categorically displayed on four user selected pages.
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