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510(k) Data Aggregation

    K Number
    K221179
    Device Name
    SomnoMetry
    Manufacturer
    Neumetry Medical Inc
    Date Cleared
    2022-09-21

    (149 days)

    Product Code
    OLZ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neumetry Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SomnoMetry is intended for use for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults only. SomnoMetry is a software-only medical device to be used to analyze physiological signals and automatically score sleep study results, including the staging of sleep, AHI, and detection of sleepdisordered breathing events including obstructive apneas. It is intended to be used under the supervision of a clinician in a clinical environment. All automatically scored events are subject to verification by a qualified clinician.
    Device Description
    The SomnoMetry is an Artificial Intelligent/Machine Learning (AI/ML)-enabled Software as a Medical Device (SaMD) that automatically scores sleep study results by analyzing polysomnography (PSG) signals recorded during sleep studies. It is intended to be used under the supervision of a clinician in clinical environments to aid in the diagnosis of sleep and respiratory related sleep disorders. All scored events that are analyzed, displayed, and summarized can be manually marked or edited by a qualified clinician during review and verification. SomnoMetry consists of: - A web Application Programing Interface (API) to allow authenticated users to upload . PSG files to SomnoMetry Platform - A database to store the input, intermedium output, final output, and associated data ● - A database API to access the database and store/retrieve the output ● - A dashboard to display, retrieve, manage, edit, verify, and summarize the output - An AI/ML Engine using AI/ML algorithms/approaches to analyze PSG data ● - A reporting API to generate sleep reports
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