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510(k) Data Aggregation

    K Number
    K123937
    Device Name
    ATOM TRANSCAPSULE V-707
    Manufacturer
    ATOM MEDICAL CORPORATION
    Date Cleared
    2013-05-23

    (154 days)

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

    ATOM MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates.
    Device Description
    The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates. It is intended to be used in hospitals, delivery suites, NICU, and transport. The Transcapsule V-707 controls temperature based on air temperature within the incubator. The front panel shows set temperature and the actual temperature. The heat source is electrically powered and can be set between 23.0 to 38.0℃ in 0.1℃ increments. The measured temperature within the incubator has a range of 20.0-42.0℃ in 0.1℃ increments with an accuracy of +/-1.0°C. It can also show skin temperature of the infant between 30.0 and 42.0°C in 0.1°C increments with an accuracy of +/-0.3℃. The Transcapsule V-707 can be mounted in a variety of mechanical configurations, the HL Stand for transport and Cabinet Stand for internal hospital use are typical examples, see Section 11 for further details. The HL Stand for transport and the Cabinet Stand for internal hospital use (and oxygen gas cylinder) are not included in this submission. The Transcapsule V-707 consists of a hood, a main body, a control panel and an external power pack which provides DC power to the incubator. The external power pack also contains batteries to allow for operation when external power is lost. The battery is automatically kept charged when there is an external source of power provided to the device. Battery status (charging and capacity) is indicated on the power pack. The device provides audible and visual alarms for: High temperature, set point, power failure, fan, system failure, silence, skin temperature probe, low voltage (when the voltage from the battery or the external DC power source falls to approx. 10.5V). The device complies with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-20.
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    K Number
    K120937
    Device Name
    SUNFLOWER WARNER
    Manufacturer
    ATOM MEDICAL CORPORATION
    Date Cleared
    2012-07-06

    (100 days)

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

    ATOM MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sunflower Warmer is intended for thermoregulation, skin temperature monitoring, and Apgar timing of newborn infants.
    Device Description
    The Sunflower Warmer is a radiant-warming open-type incubator for newborns and premature neonates. It is intended for pre-operative and post-operative intensive care in neonatal surgery, temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, etc. The Sunflower Warmer has the capability to control the infant's skin temperature as well as the CPR timer. It is provided in eight mechanical variants, the canopy (heat source) is identical in all variants.
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    K Number
    K111547
    Device Name
    BILI-THERAPY PAD TYPE
    Manufacturer
    ATOM MEDICAL CORPORATION
    Date Cleared
    2012-04-12

    (314 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATOM MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BILI-THERAPY Pad Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia.
    Device Description
    The BILI-THERAPY Pad Type is a Bili-therapy unit available with large and small pads. The light source can be mounted to the incubator / warmer or an optional stand. The unit provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital / institutional settings. The BILI-THERAPY Pad Type emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia. Light is generated in the light source and conducted to the patient via light guides to the pads are reusable and are intended to be covered with disposable pad covers. Eye masks are recommended for use with this product but are not included in this submission. Reference to commercially available eye masks is provided in the instructions for use.
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    K Number
    K103317
    Device Name
    RESUSCITATION UNIT 105
    Manufacturer
    ATOM MEDICAL CORPORATION
    Date Cleared
    2011-04-20

    (161 days)

    Product Code
    BZR
    Regulation Number
    868.5330
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATOM MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Resuscitation Unit 105 PV and Resuscitation Unit 105 EV are intended to remove secretions from the neonatal / infant airways and to provide blended air and oxygen at a desired oxygen concentration in the range of 21-100% to a respiratory assist device connected to the patient such as a ventilator (including a manually operated one) and an oxygen tent. Environment of use - Hospitals, delivery suites, NICU
    Device Description
    There are two (2) models of the Resuscitation Unit 105 air / oxygen blender with suction. - Resuscitation Unit 105PV . - . Resuscitation Unit 105EV They have the same basic design. Table 1 outlines the basic features and differences of each model.
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    K Number
    K102542
    Device Name
    RESUSCI FLOW; RESUSCI FLOW 104
    Manufacturer
    ATOM MEDICAL CORPORATION
    Date Cleared
    2011-04-06

    (215 days)

    Product Code
    BTL
    Regulation Number
    868.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATOM MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Resusci Flow series (Resusci Flow and Resusci Flow with blender) is a manually operated ventilator intended to assist a doctor in resuscitating an infant who has spontaneous breathing by providing the positive end-expiratory pressure (PEEP) and the peak inspiratory pressure (PIP). The Resusci Flow series (Resusci Flow 104 PV and Resusci Flow 104EV) is intended for resuscitation of neonates in a delivery room and a NICU. It is used to remove secretions from the neonatal mouth and nostrils or to ventilate or assist in ventilating neonates suffering from apnea or other respiratory failure. All are intended for neonates and infants (≤ 10kg or 22 lbs) in a delivery room and a NICU.
    Device Description
    There are four (4) models of the Resusci Flow resuscitator. - Resusci Flow ● - Resusci Flow with blender ● - Resusci Flow 104PV . - Resusci Flow 104EV . They all have the same basic design. Table 1 outlines the basic features and differences of each model.
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    K Number
    K103828
    Device Name
    BILI-THERAPY SPOT TYPE
    Manufacturer
    ATOM MEDICAL CORPORATION
    Date Cleared
    2011-03-29

    (91 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATOM MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BILI-THERAPY Spot Type is a phototherapy unit intended for the treatment of neonatal hyperbilirubinemia.
    Device Description
    The BILI-THERAPY Spot Type is an overhead unit available in two versions: Arm and Stand. The BILI-THERAPY Spot Type phototherapy unit shines a blue light onto the patient for the treatment of hyperbilirubinemia. The unit has no direct contact with the patient.
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    K Number
    K102227
    Device Name
    INFA WARMER I
    Manufacturer
    ATOM MEDICAL CORPORATION
    Date Cleared
    2011-01-21

    (165 days)

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

    ATOM MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infa Warmer i is a radiant-warming open-type incubator for newborns and premature neonates. It is intended for pre-operative and post-operative intensive care in neonatal surgery, temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, etc. The Infa Warmer i is provided with the temperature control function to control the infant's skin temperature and optional functions include pulse oximetry and oxygen density controlling,
    Device Description
    Infa Warmer i (Atom Infant Warmer Model 103) consists of a canopy, a warming heater (heater), a pole, a control panel, a mattress, a mattress platform, baby guards and a stand with casters. This product has 3 types (Type Name: HE, MS, ST) according to the following specification. HE: (1)With mattress platform, stand can go up and down MS: (2)With mattress platform, stand cannot go up and down ST: (3)Without mattress platform A warming heater is installed in the canopy. Skin temperature sensors are connected to front panel of the pole. This product has 2 types of function modes; one is "servo control model" (called as "skin temperature control mode") and another is manual control mode. In "servo control mode", skin temperature can be set from 34°C to 38°C In "bel to control mode", heater output of the warming heater can be set from 0 to 100% (in 5% increments). When the product is functioned in "servo control mode", baby's skin temperature is monitored by temperature sensor attached on baby's body, and baby's skin temperature is controlled according to difference between monitored baby's skin temperature and set skin temperature. When the product is functioned in "manual control mode", heater output of the warming heater is controlled manually according to measured baby's skin temperature. The mattress platform can be tilted. The mattress platform can be tilted. The skin temperature sensors and X-ray cassette tray The skin temperature sensors and X-ray cassette tray are accessories. The X-ray cassette tray is optional accessory, and it can be installed under the mattress platform. These accessories are available separately as replacements. SpO2 module is component of this product, and it is optional whether they are attached initially or not. If it is not attached initially, it can be attached later, and SpO2/pulse monitoring can be available. The component can be supplied individually. This product has a space inside the pole, and gas powered resuscitator or oxygen/air gas blender whose sizes are within the space, can be installed in the space, so that resuscitation or oxygen therapy can be done immediately for any new born baby who needs such the treatments. When the resuscitator or the blender is installed in this space, it is completely separated from this product, and it does not have any connections with this product regarding function, operation and power source. Therefore, this product operates normally without the resuscitator or the blender. Also, this product operates normally, even if the resuscitator or the blender is out of order.
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    K Number
    K102226
    Device Name
    DUAL INCU I
    Manufacturer
    ATOM MEDICAL CORPORATION
    Date Cleared
    2011-01-04

    (148 days)

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

    ATOM MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dual Incu i is a combination of an infant incubator and an infant warmer. The device can transition from one mode to the other on user's demand. The Dual Incu i is an incubator for newborns and premature neonates. It is mainly intended for temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. This incubator is provided with a function to control the infant's skin temperature. Optional functions include pulse oximetry and oxygen density controlling.
    Device Description
    Dual Incu i (Atom Infant Incubator Model 100) is a combination of an infant incubator and an infant warmer. This device consists of hood, a main body, a control panel and a warming heater (radiant warmer) and a stand with casters. A hood consists of a canopy and access doors (snapopen access port). An Oxygen sensor, a humidity sensor and a temperature sensor which monitor the air conditions inside the hood, are connected to the sensor module. A main body consists of a mattress, a mattress platform, a conditioning chamber, a humidity chamber. A control panel and skin temperature sensors are connected to the main body. This device has a function that elevates the canopy. The device operates as an incubator when the canopy is closed, and the device operates as a radiant warmer when the canopy is opened. This product has 2 types of function modes; one is "servo control mode" (called as "skin temperature control mode" also) and another is "manual control mode". When the device is operated as an incubator, skin temperature can be set from 34° to 38° (including override) in "servo control mode", and air temperature inside the hood can be set from 23 ° to 39 ° (including override) in "manual control mode". When the device is operated as an infant warmer, skin temperature can be set from 34° to 38° (including override) also in "servo control mode", and heater output of the warming heater can be set from 0 to 100%(in 5% increments) in "manual control mode". In "servo control mode", baby's skin temperature is monitored by temperature sensor attached on baby's body, and baby's skin temperature is controlled according to difference between monitored baby's skin temperature and set skin temperature. In "manual control mode", air temperature inside the hood is monitored by temperature sensor of sensor module, and air temperature inside the hood is controlled according to difference between monitored air temperature inside the hood and set air temperature, when the device is operated as an incubator. The mattress platform can be tilted. X-ray cassette tray is installed under the mattress platform. The device has 6 kinds of accessories: "Skin temperature sensor", "Oxygen sensor", "Piping hose for oxygen", "Electrostatics air filter", "Access port cover" and "Oxygen calibration tool", and these 6 accessories are available separately as replacements. "SpO2 Module", "Oxygen Controller", "Weight Monitor" and "Humidifier Chamber" are components of this device, and it is optional whether they are initial attached initially or not. If they are not attached initially, they can be attached later, and then SpO2/pulse monitoring, oxygen density controlling, weight monitoring and humidifying function can be available. The 4 kinds of components can be supplied individually. The stand can go up and down.
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    K Number
    K102279
    Device Name
    INCU I
    Manufacturer
    ATOM MEDICAL CORPORATION
    Date Cleared
    2010-12-29

    (140 days)

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

    ATOM MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Incu i is an incubator for newborns and premature neonates. It is mainly intended for temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. This incubator is provided with a function to control the infant's skin temperature. Optional functions include pulse oximetry, and oxygen density controlling.
    Device Description
    Incu i (Atom Infant Incubator Model 101) consists of a hood, a main body, a control panel and a stand with casters. A hood consists of a canopy and access doors (Snap-open access port). An Oxygen sensor, a humidity sensor and a temperature sensor which monitor the air conditions inside the hood, are connected to the sensor module. A main body consists of a mattress, a mattress platform, a conditioning chamber, a humidity chamber. A control panel and skin temperature sensors are connected to the main body. This product has 2 types of function modes; one is skin temperature control mode and another is air temperature control mode. The skin temperature control mode is called "servo control mode" also, and the air temperature control mode is called "manual control mode" also. In "servo control mode", skin temperature can be set from 34°C to 38°C (including override). In "manual control mode", air temperature inside the hood is monitored by temperature sensor of sensor module, and air temperature inside the hood is controlled according to difference between monitored air temperature inside the hood and set air temperature. The mattress platform can be tilted. X-ray cassette tray is installed under the mattress platform. The device has 6 kinds of accessories; "Skin temperature probe (sensor)", "Oxygen sensor", "Piping hose for oxygen", "Electrostatics air filter", "Access port cover" and "Oxygen calibration tool", and these 6 accessories are available separately as replacements. "SpO2 Module", "Oxygen Controller", "Weight Monitor" and "Humidifier Chamber" are components of this device, and it is optional whether they are initial attached initially or not. If they are not attached initially, they can be attached later, and then SpO2/pulse monitoring, oxygen density controlling, weight monitoring and humidifying function can be available. The 4 kinds of components can be supplied individually. The stand can be gone up and down.
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    K Number
    K102710
    Device Name
    NEO-SERVO I
    Manufacturer
    ATOM MEDICAL CORPORATION
    Date Cleared
    2010-12-22

    (93 days)

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

    ATOM MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neo-Servo i Atom Infant Incubator Model 102 is a closed-type incubator for newborns and premature neonates. It is mainly intended for temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. The incubator is provided with a function to control the infant's skin temperature.
    Device Description
    The Neo-Servo i Atom Infant incubator Model 102 consists of a hood, a main body, a control panel and is offered with or without a stand with casters. The Model 102 incorporates two (2) modes of control: air (manual control) and baby (servo control). The Model 102 incorporates the sensors (humidity and temperature) inside the hood monitor the air conditions inside the hood. These are connected to the Sensor module. It is equipped with an incubator air temperature control function to circulate air containing the heat generated b 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. It is equipped with a skim temperature control function o maintain the infant's skin temperature at a fixed level in response to the patient's temperature as measured by the skin probe. There are optional humidity chamber and x-ray cassette tray. There are 2 functional modes: - Skin temperature control mode referred to as "Servo Control Mode" 1. - Air temperature control mode referred to as "Manual Control Mode" 2.
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