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510(k) Data Aggregation

    K Number
    K021809
    Device Name
    V-2100G ADVANCED INFANT INCUBATOR
    Manufacturer
    ATOM MEDICAL CORP.
    Date Cleared
    2002-07-18

    (45 days)

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

    ATOM MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The V-2100G Advanced Infant Incubator is a hooded container that is intended to provide a controlled thermal environment and isolation from ambient air for premature and neonatal infants. The V-2100G is not intended for the transport of infants.
    Device Description
    The V-2100G Infant Incubator provides standard functions to control the incubator temperature, either by manual (air) or servo (baby) control, and air humidity. The incubator also provides an external communication function that allows data to be exported to the user's PC for evaluation and storage. In addition, the incubator provides the following optional functions: oxygen controller, pulse oximeter, and weight monitor. The temperature in the incubator can be controlled using one of two modes: manual control mode or servo control mode. In manual control mode, the incubator air temperature is controlled to maintain the desired infant temperature. The air temperature is initially set based on the user's training and experience and is then adjusted based on the infant's needs and clinical status. In the servo control mode, a skin temperature probe is attached to the infant and is monitored by the incubator controller. The heater output is controlled to maintain the infant's skin temperature at a set value. Changes to the heater output are made gradually, so as to minimize temperature overshoot and infant stress.
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    K Number
    K002355
    Device Name
    ATOM INFA WARMER V-505
    Manufacturer
    ATOM MEDICAL CORP.
    Date Cleared
    2000-10-10

    (69 days)

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

    ATOM MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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