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510(k) Data Aggregation

    K Number
    K233775
    Device Name
    Vivatmo pro
    Manufacturer
    Bosch Healthcare Solutions GmbH
    Date Cleared
    2024-02-22

    (90 days)

    Product Code
    MXA
    Regulation Number
    862.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bosch Healthcare Solutions GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vivatmo pro nitric oxide test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO is increased in some airway inflammatory processes, such as asthma, and often decreases in response to anti-inflammatory treatment of FeNO by Vivatmo pro is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti- inflammatory pharmacological therapy as an indication of therapeutic effect in patients with elevated FeNO measurements are to be used as an adjunct to established clinical assessments.
    Device Description
    Vivatmo pro nitric oxide test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath.
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