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510(k) Data Aggregation

    K Number
    K230148
    Device Name
    Vlab
    Manufacturer
    DormoTech Medical Ltd.
    Date Cleared
    2023-10-11

    (265 days)

    Product Code
    GWL, MNR
    Regulation Number
    882.1835
    Why did this record match?
    Applicant Name (Manufacturer) :

    DormoTech Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DormoTech Vlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician is intended for use on adults in a supervised (hospital) or unsupervised (home) environment.
    Device Description
    The DormoTech Vlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It consists of: The Head Unit, The Body Unit, and The Central Unit.
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