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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 ?
510(k)
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.
FDA-Cleared Indications
- Assessment of respiratory function using spirometric measurements.
- Use in patients with suspected or known disorders affecting breathing.
- Collection, analysis, and reporting of data obtained from compatible spirometry equipment.
Clinical Applications
- Supporting pulmonary function testing in respiratory clinics and laboratories.
- Generating numerical results and graphical displays from spirometry examinations.
- Helping clinicians evaluate airflow and lung-capacity measurements in patients with respiratory symptoms or known lung disease.
- Providing documented spirometry results for clinical assessment and follow-up.
Practical Considerations
- This is a software interface rather than an implanted or patient-contacting device; it requires compatible spirometry equipment and a suitable computer system.
- Compatibility depends on the specific Vitalograph spirometer, interface hardware, operating system, and software configuration.
- Spirometers and associated equipment should be calibrated, maintained, and used according to the manufacturer’s instructions to support reliable measurements.
- The interface itself is not an MRI device and should not be taken into the MRI environment unless the complete computer and equipment configuration has been specifically cleared for that use.
- The software does not replace appropriate patient coaching, quality-control checks, or clinician interpretation of spirometry 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.