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510(k) Data Aggregation

    K Number
    K061856
    Device Name
    V-2200 INFANT INCUBATOR
    Manufacturer
    ATOM MEDICAL INC
    Date Cleared
    2006-09-28

    (90 days)

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

    ATOM MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V-2200 Infant Incubator is a device to keep premature infants or neonatal infants in a warm environment which is covered by a hood and isolated from ambient air and of which internal air temperature and humidity, are controlled. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities. Optional functions include pulse oximetry and oxygen delivery. This device is not intended for home use. This device is not intended as a transport incubator. This is a prescription device.
    Device Description
    This product consists of a hood, a sensor module, a mattress platform, a middle deck section, a conditioning chamber, a humidity chamber, an operation control section, a power source, a relay box, an oxygen supply/filter box, a pulse oximeter, an oxygen controller and a weight monitor. It is equipped with an incubator air temperature control function to circulate the air containing the heat energy generated by the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level. The device is also equipped with a skin temperature control function to maintain the infant's skin temperature at a fixed level in response to the patients temperature as measured by the skin probe. There is a humidity control function to adjust the amount of vapor generated in the humidity chamber. The following additional features can be installed into the incubator: a pulse oximeter function to monitor Sp02 concentration and pulse rate non-invasively; an oxygen control function to draw oxygen and outside air and control the oxygen concentration delivered to the patient compartment to the desired level; and a weight monitor to facilitate taking the infants weight without moving them from the incubator. This device is designed to be used in treatment, procedures and observation of low-birth-weight and sick neonates, providing heat to the neonate when the body temperature is low and also to provide humidity if desired
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    K Number
    K061071
    Device Name
    V-808 ATOM TRANSCAPSULE
    Manufacturer
    ATOM MEDICAL INC
    Date Cleared
    2006-08-29

    (134 days)

    Product Code
    FPL
    Regulation Number
    880.5410
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATOM MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V-808 Atom Transcapsule is a neonatal transport incubator. The incubator is a device with a transparent hood intended to contain a premature infant or a neonatal infant within the compartment covered by said hood and intended to safely convey the infant accommodated in that compartment, providing the infant with isolated environment from ambient air where temperature - controlled air is supplied. The V-808 also provides oxygen monitoring and supply as well as an integrated pulse oximetry capability. This device is not intended for home use. This is a prescription device.
    Device Description
    This product consists of a hood section, a mattress platform section, a middle deck section, a conditioning chamber section, an operation section and a pedestal section. It is equipped with an incubator air temperature control function to circulate the air containing the heat energy generated by the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level, an oxygen supply function to deliver oxygen into the inner hood from outside, and a function to determine and display the oxygen concentration of the endosed compartment covered by the hood. It is further equipped with a function to measure and display the skin temperature of the neonate, as well as a pulse oximeter function to determine oxygen saturation and pulse rate non-invasively. It is a transport incubator, wherein said functions are intended to be used in treatment, procedures and observation of low-birth-weight and sick neonates, allowing provision of heat to the neonate when the body temperature is low.
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    K Number
    K060461
    Device Name
    V-505 INFA WARMER
    Manufacturer
    ATOM MEDICAL INC
    Date Cleared
    2006-04-28

    (65 days)

    Product Code
    FMT
    Regulation Number
    880.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATOM MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V-505 Atom Infa Warmer is a radiant warming, open type incubator intended to provide an optimum clinical environment for observation, examination, temperature regulation, and management of neonates. Optional functions include pulse oximetry and oxygen delivery. This device is not intended for home use. This is a prescription device.
    Device Description
    The Atom Infa Warmer V-505 is designed to maintain an infants body temperature by means of infrared radiant heat emitted from a heater located above the mattress. Temperature control is achieved either by manual adjustment of the heater output or by servo control based on changes in the infants skin temperature. All models of the V-505 may also be purchased with the following optional functions: a pulse oximeter that measures the infant's SpO2 and pulse rate, an oxygen delivery system consisting of either an oxygen blender or an oxygen flowmeter, and a suction unit. Other device features (depending on the model) include a timer, illumination lamps, an RS232 connector for communication with an external computer, a rotating/tilting canopy, a tilting mattress platform, baby quards, and support column rails for attaching an optional tray set or IV pole.
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