Search Results
Found 1 results
510(k) Data Aggregation
K Number
K233775Device Name
Vivatmo pro
Manufacturer
Bosch Healthcare Solutions GmbH
Date Cleared
2024-02-22
(90 days)
Product Code
MXA
Regulation Number
862.3080Why 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.
Ask a Question
Page 1 of 1