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510(k) Data Aggregation

    K Number
    K963597
    Device Name
    SILENT NIGHT I
    Manufacturer
    LOCAL SILENCE, INC.
    Date Cleared
    1997-01-23

    (136 days)

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

    LOCAL SILENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silent Night I is indicated for use in the diagnostic evaluation of adults with possible Obstructive Sleep Apnea. It is intended to record a patient's respiratory pattern. The device is designed for use in home screening of adults with possible sleep disorders.
    Device Description
    The Silent Night I (SNI) consists of a metal box measuring approximately 23 centimeters wide by 17 centimeters deep by 7.5 centimeters high. The device is portable, line-powered and weighs approximately three pounds. The box contains the operational components of the device and has two receptacle connectors: one for input power and another for the sensing microphone. This microphone is attached to the SNI by means of an eight-foot flexible cable and connector. Another microphone is built into the rear of the box and senses room ambient noise. A POWER switch is located on the back of the unit. A switch enabling the user to PAUSE and RESUME device operation is located on the side of the unit. The device operates as follows: the sound field (breathing sounds + room ambient noise) is sensed by the two microphones and sent to the controller, which extracts breathing sounds from all sounds received. These signals are then sent through bandpass filters and the amplitude characteristics of the signals in the frequency realm are analyzed. The signals are then processed by the pattern recognizer, which differentiates between types of sounds and classifies them as regular snoring or breathing, hypopnea, or apnea. These classified events are logged cumulatively and shown on a liquid crystal display as Disordered Breathing Events (DBE) on the front control panel of the device.
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