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510(k) Data Aggregation

    K Number
    K030611
    Device Name
    MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM
    Date Cleared
    2003-03-24

    (26 days)

    Product Code
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    NELLCOR PURITAN BENNETT (MELVILLE) LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nellcor Puritan Bennett Suzanne is intended for use in collecting and recording physiological data to be used in diagnosing sleep disorders. A pediatric through adult patient population is intended for the Suzanne, which can be used in either home or hospital environments.
    Device Description
    The Suzanne System is composed of a data recorder that contains the electronics and software necessary to capture the physiological information of each sensor and to store this information in a Flash card or to send it to a computer via a serial communication port. The information that can be recorded by the Suzanne System is : - · EEG signals - · ECG signals - · Pressure signals - · Thoracic movements - Abdominal movements - Breath detection (through bucco-nasal thermistor) . - Flow (through pneumotachometer) - Envelope of ambient sound . - Body position . - Ambient light detection . - Arterial oxyhemoglobin saturation (SpO2) . - Pulse rate . The signals are amplified by different amplifiers contained in elements of the system known as headboxes. When used in a home environment, the data is recorded in the flash card and the clinician uses a setup unit to check that the system works correctly and to set the recording starting time. When used in a clinical environment, the system can be used as described above or data can be recorded to a computer with the use of a PC application software. The system is powered by an internal battery or by a DC power supply.
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