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510(k) Data Aggregation

    K Number
    K253293

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-03

    (65 days)

    Product Code
    Regulation Number
    870.2800
    Age Range
    8 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Vitalograph VitaloJAK Clinic Model 7100 is indicated for use to aid in the assessment of cough in adults and pediatric patients aged 8 years and older under supervision presenting with suspected Chronic Cough.

    The Vitalograph VitaloJAK Clinic Model 7100 is a non-invasive battery-operated device intended to acquire, record and store ambulatory cough sounds from patients. The device stores the data on internal memory for later playback, review, and analysis on a windows-based PC.

    Device Description

    The Vitalograph VitaloJAK Clinic Model 7100 is a non-invasive battery-operated device intended to acquire, record and store ambulatory cough sounds from patients. The device stores the data on a removable memory card or internal memory for later playback, review, and analysis on a windows-based PC.

    The Vitalograph VitaloJAK Clinic Model 7100 is indicated for use in cough recording sessions. It provides the means to sense voice and cough activity from a subject, record this information and store it on an SD memory card. The Vitalograph VitaloJAK Clinic Model 7100 is not life supporting equipment, it does not screen, treat or prevent any condition or disease. The subjects may be of any user population, weight range, health, or condition.

    AI/ML Overview

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