đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Assessment of pulmonary function in infants and young children.
- Measurement of respiratory parameters, including lung volumes and airway resistance, during pediatric pulmonary evaluation.
Clinical Applications
- Pulmonary function assessment in infants with suspected respiratory disease.
- Evaluation of lung function in young children who cannot use standard adult pulmonary testing equipment.
- Objective respiratory assessment to support the clinical evaluation and management of pediatric lung disorders.
Practical Considerations
- The device is intended for pediatric patients and requires appropriately sized interfaces for infants and young children.
- Accurate testing depends on trained pediatric pulmonary-function personnel, proper patient positioning, cooperation or an appropriate testing protocol, and routine calibration.
- The device measures respiratory function and does not itself diagnose asthma, cystic fibrosis, bronchopulmonary dysplasia, or other lung diseases.
- The FDA record does not establish that the device is MRI safe or MRI conditional; it should not be taken into an MRI environment unless the manufacturer provides specific clearance.
- Use should be guided by the treating clinician, with attention to the child's ability to tolerate the testing interface and any clinical contraindications to pulmonary function testing.
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.