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510(k) Data Aggregation

    K Number
    K232588
    Device Name
    Aluna 2
    Manufacturer
    Knox Medical Diagnostics
    Date Cleared
    2024-11-25

    (458 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Knox Medical Diagnostics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aluna 2 is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate) for home use. The device is designed for pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.
    Device Description
    Aluna 2 consists of three main components: - A small hand-held peak flow meter that captures differential pressure, converts it to digital data points, and transmits the data to a mobile device via Bluetooth. - A mobile application that collects and transmits the differential pressure readings from the spirometry device and processes it to estimate the exhaled air flow rate and volume. - An Application Programming Interface (API) to facilitate communication with a cloud server used for data storage.
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    K Number
    K193311
    Device Name
    Aluna
    Manufacturer
    Knox Medical Diagnostics, Inc.
    Date Cleared
    2020-03-25

    (117 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Knox Medical Diagnostics, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Aluna is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate) for home use. The device is designed for children 5 years of age or older, adolescent and adult subjects. Additionally, the device may be used by clinicians for in-office monitoring.
    Device Description
    Aluna is a small hand-held peak flow meter that captures lung health information and makes it available through a mobile application. Aluna is intended for monitoring FEV1 (Forced Expiratory Volume in one second) and PEF (Peak Expiratory Flow) for over-the-counter use. Aluna is designed for use by pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.
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