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510(k) Data Aggregation

    K Number
    K061256
    Device Name
    SMARTMONITOR 2PS
    Manufacturer
    Date Cleared
    2006-08-02

    (90 days)

    Product Code
    Regulation Number
    868.2377
    Why did this record match?
    Product Code :

    NPF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SmartMonitor 2PS is intended for use in the continuous monitoring of respiration, heart rate and SpO2 levels of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, high or low breath rate, and high or low saturation. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment. The SmartMonitor 2PSL is intended for use in the continuous monitoring of respiration, and heart rate of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, and high or low breath rate. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment.
    Device Description
    The SmartMonitor 2PS is a microprocessor-based, software-controlled device intended for use as an infant apnea monitoring system or as an adult or pediatric vital signs monitoring system. The electromechanical design of the SmartMonitor 2PS is unchanged from the SmartMonitor 2PS (K032403) except that cleared ECG and oximetry sensor accessories have been selected for adult and pediatric use of the monitor.
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    K Number
    K032403
    Device Name
    SMARTMONITOR 2 PROFESSIONAL SERIES (PS)
    Manufacturer
    Date Cleared
    2003-10-27

    (84 days)

    Product Code
    Regulation Number
    868.2377
    Why did this record match?
    Product Code :

    NPF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SmartMonitor® 2 Professional Series Infant Apnea Monitor is intended for use in the continuous monitoring of respiration, heart rate, and SpO2 of infant patients in a hospital or home environment. The monitor detects and alarms for periods of central apnea, high or low heart rate, and high or low saturation.
    Device Description
    The SmartMonitor 2PS is a microprocessor-based, software-controlled device intended for use as an infant apnea monitoring system. The SmartMonitor 2PS is designed to analyze and record physiologic signals (ECG, respiration, SpO2 and pulse rate) acquired from infant patients during sleep. Its primary function is to analyze the physiologic signals and generate visual and audible alarm indications upon detection of physiologic events such as central apnea, bradycardia, and high or low SpO2. The portable design of the device facilitates its use in a hospital or in a home environment. ECG and respiration signals are acquired via a single transducer set attached to the patient and directly connected to the monitor. The measurement method used to derive the respiration signal is Transthoracic Impedance. SpO2 and plethysmographic pulse rate acquired via an oximeter finger sensor. The acquired physiologic signals are classified and stored for use at a later time. A Host PC may interface to the SmartMonitor 2PS via a direct serial connection for the purpose of downloading the monitor's previously stored data and/or retrieving the monitor's real time data. The SmartMonitor 2PS is a compact, lightweight unit. Two front panel connectors are provided for the patient sensor input. The sensor connectors and associated sensor plugs are individually keyed to prevent improper insertion. The SmartMonitor 2 is approximately 7.4 inches wide, 10 inches deep and 2.5 inches high. It weighs approximately 2 pounds. The enclosure for the monitor is constructed of plastic injection molded materials. Components and assemblies are securely mounted inside. The enclosure design is resistant to the entrance of liquids and other foreign materials.
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