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510(k) Data Aggregation

    K Number
    K182859
    Device Name
    Babyleo TN500
    Manufacturer
    Dragerwerk AG & Co. KGaA
    Date Cleared
    2019-02-22

    (134 days)

    Product Code
    FMZ, BAB, FMT
    Regulation Number
    880.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Dragerwerk AG **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Babyleo TN500 is intended for use with premature babies and neonates and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally requlated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator. Neonates are kept warm in the patient compartment with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: Temperature; Humidity; Oxygen (option).
    Device Description
    The device Babyleo TN500 is a medical device used to maintain environmental conditions suitable for preterm babies and neonates. The important features are temperature and humidity. The operational principle is a combination of a neonatal incubator and an open warmer. Babyleo TN500 can be operated in closed care therapy as an incubator according to IEC60601-2-19 or in open care therapy as a warmer according to IEC60601-2-21. Additionally, an optional x-ray translucent heated mattress is intended to provide sensible heat to the preterm babies and neonates. The device consists of the following components: Incubator (=bassinet) with a convection heater and closed humidification system for the patient, trolley, radiant warmer, display, mattress, x-ray tray and height adjustment. Optional components are scale, heated mattress, drawer, oxygen regulation with cylinder holder and Auto Thermo package and Developmental Care package. The subject of this submission is the addition of the optional Touch time function, which can be activated in order to stabilize the thermal environment in the patient compartment when the hand ports are opened. It supports users during routine tasks (e.g. changing diapers, washing the baby, checking sensors). Additionally, the scale resolution is changed from 5q to 10g.
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    K Number
    K180779
    Device Name
    Savina 300
    Manufacturer
    Dragerwerk AG & CO. KGaA
    Date Cleared
    2019-01-17

    (297 days)

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

    **Dragerwerk AG **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intensive care ventilator Savina 300 is intended for the ventilation of adults, adolescents, children, and infants starting from 5 kg (11 lbs) body weight. Savina 300 offers mandatory ventilation modes, ventilation modes supporting spontaneous breathing, and airway monitoring. Savina 300 is intended for the following environments of use: - In intensive care wards, in recovery rooms and generally for hospital use - During the transfer of ventilated patients within the hospital
    Device Description
    Savina 300 is a turbine driven ventilator with a 12.1" color touch screen, providing tube and mask based ventilation capabilities. Air is taken from ambient. O2 can be taken from central gas supply, bottle supply (with appropriated accessories) or from another low pressure oxygen source (LPO). Savina 300 is intended for the ventilation of adults, adolescents, children, and infants starting from 5 kg (11 lbs) body weight in intensive care units, in recovery rooms and generally for hospital use. Savina 300 can also be used during transport of ventilated patients within the hospital. The ventilation unit of the Savina 300 is a microprocessor-controlled ventilator. The Savina 300 provides positive pressure ventilation and adjustable oxygen concentration with pressure- and volume-controlled automatic and spontaneous breathing modes.
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