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    K Number
    K172986
    Device Name
    Zmachine Synergy
    Manufacturer
    Consolidated Research of Richmond, Inc. dba General Sleep Co
    Date Cleared
    2017-12-19

    (83 days)

    Product Code
    OLV, MNR, OMC
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Consolidated Research of Richmond, Inc. dba General Sleep Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Zmachine Synergy is an EEG and respiratory signal recorder. The device is intended for use by adult patients in the home or clinical environment, under the direction of a qualified healthcare practitioner, to aid in the diagnosis of sleep disorders.
    Device Description
    The Zmachine Synergy system is a portable, battery operated, medical device housed within an ABS enclosure. The system combines the single-channel EEG recording capability of the Zmachine DT-100 (K101830) with the respiratory signal recording capability of the Resmed ApneaLink Air (K143272). The Zmachine Synergy is thereby capable of recording EEG, respiratory airflow, respiratory effort, blood oxygen saturation, pulse rate, and body position during sleep.
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