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510(k) Data Aggregation

    K Number
    K183364
    Device Name
    Bellavista
    Manufacturer
    Imtmedical AG
    Date Cleared
    2019-09-13

    (283 days)

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

    Imtmedical AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients and optionally infant and neonatal patients by qualified, trained personnel under the direction of a physician. Environment of use: hospitals, sub-acute care facilities and intra-hospital transfer When used on neonatal patients: The environment of use is the Neonatal Intensive Care Unit (NICU).
    Device Description
    bellavista is an electronically controlled pneumatic ventilation system. It is powered by AC or DC and also provided with an internal battery. The bellavista pneumatic system supplies respiratory gas whilst the electrical systems control the pneumatics and provides the power supply. The user can enter values or parameters in the bellavista via the touch screen. These inputs entail instructions for bellavista's pneumatic system to ventilate the patient with a precisely controlled gas mixture. bellavista gathers readings from the proximal flow sensor within the ventilator.
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    K Number
    K163127
    Device Name
    bellavista 1000
    Manufacturer
    IMTMEDICAL AG
    Date Cleared
    2017-07-31

    (265 days)

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

    IMTMEDICAL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bellavista 1000 ventilator is intended to provide positive pressure ventilator support to adults and pediatrics (IBW greater than 6 kg). Environment of use: hospitals, sub-acute care facilities and intra-hospital transfer It is intended for use by qualified, trained personnel under the direction of a physician.
    Device Description
    The bellavista 1000 ventilator (hereafter referred to as "bellavista") is designed for continuous ventilation of adult and pediatric patients. The bellavista ventilator is a positive pressure ventilator for intubated patients and patients with mask ventilation. Its pneumatic power is provided by an internal turbine. Supplemental oxygen is provided by an auxiliary oxygen source. The following modes of ventilation are available - Adults: CPAP, PCV, P-A/C, PC-SIMV, PSV, S, S/T, T, beLevel, APRV, VCV, ● V-A/C, VC-SIMV. - Pediatrics the following modes of ventilation are available: CPAP, PCV, P-A/C, ● PC-SIMV, S, T, beLevel, APRV, VCV, V-A/C, VC-SIMV
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