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masterscreen paed - baby body
Viasys Healthcare
Summary: The masterscreen paed - baby body is a medical device designed for pediatric pulmonary function testing. It is used by pulmonologists and pediatricians to assess lung function in infants and young children.
FDA Clearance Information
Pathway
510K
Number
K081823 ↗
Decision Date
May 18, 2009
Product Code
CCM
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on May 18, 2009. Manufactured by Viasys Healthcare, it is classified as a Class 2 device under product code CCM.
What It Is
The masterscreen paed - baby body is a specialized pulmonary function testing device for infants and young children. It measures lung volumes and airway resistance, providing crucial data for diagnosing and managing respiratory conditions. The device is designed to accommodate the unique physiological characteristics of pediatric patients, ensuring accurate and reliable measurements.
Clinical Applications
This device is commonly used in pediatric pulmonology clinics and hospitals to evaluate lung function in infants with suspected respiratory disorders such as asthma, cystic fibrosis, or bronchopulmonary dysplasia. It is particularly useful in settings where detailed lung function assessment is needed to guide treatment decisions in young patients.
Indications for Use
The FDA-cleared indications include assessing lung function in infants and young children who may have respiratory conditions. It is intended for use in pediatric patients who require detailed pulmonary evaluation.
Practical Considerations
The device is designed to be compatible with pediatric patients, with sizing and interfaces suitable for infants. Clinicians should be trained in pediatric pulmonary function testing techniques to ensure accurate results. It may require specific calibration and maintenance protocols to maintain precision.
Frequently Asked Questions
What is masterscreen paed - baby body used for?
It is used for assessing lung function in infants and young children, particularly in diagnosing and managing respiratory conditions.
What specialties typically use this device?
Pediatric pulmonologists and pediatricians typically use this device in clinical settings focused on respiratory health.
What are the FDA-cleared indications?
The device is indicated for assessing lung function in pediatric patients with potential respiratory conditions.
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.