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510(k) Data Aggregation
K Number
K213754Device Name
SpiroHome Personal, SpiroHome Clinic
Manufacturer
Inofab Saglik Teknolojileri A.S
Date Cleared
2023-06-12
(559 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
Inofab Saglik Teknolojileri A.S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SpiroHome is intended to be used by adults and children over 5 years old in physician's offices, clinics and home setting to conduct basic lung function and spirometry testing.
Device Description
The SpiroHome Ultrasonic Spirometer (SUS) is a portable spirometer designed to perform pulmonary function tests in patients over the age of 5 in office (clinical) and home settings. The SpiroHome spirometer is used together with a SpiroWay mouthpiece that is inserted into and lines the entire airway of the device. SpiroHome derives pulmonary function data from airflow measurements taken by its ultrasonic sensors during a spirometry test. All of the information recorded by the device is displayed on the relevant SpiroHome app running on a Bluetoothconnected device. The pulmonary function test (PFT) data recorded by the SpiroHome device during a spirometry test is also compared against the patient's predicted values which are obtained from internationally accepted PFT equations. The user interfaces with the SpiroHome app during the entire use of the SpiroHome spirometer.
The associated accessories include: SpiroWay mouthpiece
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