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vitalograph 2110 software interface
Vitalograph
Summary: The Vitalograph 2110 Software Interface is a device used for interfacing with spirometry equipment to analyze respiratory function. It is typically used by pulmonologists and respiratory therapists in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K950854 ↗
Decision Date
October 12, 1995
Product Code
DSH
Device Class
Class 2
Evidence
0 studies
The Vitalograph 2110 Software Interface was cleared through the FDA 510(k) pathway on October 12, 1995. Manufactured by Vitalograph, it is classified as a Class 2 device under product code DSH.
What It Is
The Vitalograph 2110 Software Interface is designed to connect with spirometry devices, allowing for the collection and analysis of respiratory data. It facilitates the monitoring of lung function by providing detailed reports and graphical representations of spirometric parameters. This device is crucial in diagnosing and managing respiratory conditions by offering precise measurements of lung capacity and airflow.
Clinical Applications
This device is commonly used in pulmonary function testing laboratories and respiratory clinics. It assists healthcare professionals in diagnosing conditions like asthma, COPD, and other respiratory disorders. Pulmonologists and respiratory therapists use it to evaluate lung function in both outpatient and inpatient settings, providing essential data for treatment planning and monitoring disease progression.
Indications for Use
The FDA indications for the Vitalograph 2110 Software Interface include its use in assessing respiratory function in patients with suspected or known lung disorders. It is suitable for patients of varying ages who require spirometric evaluation to diagnose or manage conditions affecting breathing.
Practical Considerations
The Vitalograph 2110 Software Interface is compatible with a range of spirometry devices, ensuring flexibility in clinical use. It typically requires a computer system for data analysis and may involve specific software installation. Clinicians should ensure proper calibration and maintenance for accurate results.
Frequently Asked Questions
What is the Vitalograph 2110 Software Interface used for?
It is used to interface with spirometry equipment to analyze and monitor respiratory function.
What specialties typically use this device?
Pulmonologists and respiratory therapists commonly use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for assessing respiratory function in patients with suspected or known lung disorders.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.