đź“‹ FDA Reference
type interface 9271 1 incubator warmer
S & W Medico Teknik
Summary: The Type Interface 9271 1 Incubator Warmer is a medical device used to maintain optimal temperature conditions for patients, particularly in neonatal care. It is primarily used by healthcare professionals in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K912000 ↗
Decision Date
September 21, 1992
Product Code
FMZ
Device Class
Class 2
Evidence
0 studies
The Type Interface 9271 1 Incubator Warmer was cleared through the FDA 510k pathway on September 21, 1992. Manufactured by S & W Medico Teknik, it is classified as a Class 2 device under product code FMZ.
What It Is
The Type Interface 9271 1 Incubator Warmer is designed to provide a controlled thermal environment for patients, particularly newborns, who require stable temperature conditions. This device functions by regulating heat to maintain a consistent and safe temperature, which is crucial for the survival and health of premature or ill infants. Its design typically includes features like adjustable temperature settings and alarms to alert caregivers of any deviations.
Clinical Applications
This incubator warmer is commonly used in neonatal intensive care units (NICUs) to support the care of premature infants or those with medical conditions requiring precise temperature management. It is also utilized in pediatric wards and maternity hospitals. The device ensures that vulnerable patients maintain body temperature, reducing the risk of hypothermia and associated complications.
Indications for Use
The FDA indications suggest that this device is intended for use in maintaining a stable thermal environment for patients, particularly infants, who are unable to regulate their own body temperature. It is crucial for conditions where temperature stability is vital for recovery and growth.
Practical Considerations
When using the Type Interface 9271 1 Incubator Warmer, consider the size and weight of the patient to ensure appropriate settings. Compatibility with other neonatal care equipment, such as monitoring devices, should be checked. Regular maintenance and calibration are essential for optimal performance.
Frequently Asked Questions
What is the Type Interface 9271 1 Incubator Warmer used for?
It is used to maintain a stable thermal environment for patients, particularly newborns, who require precise temperature control.
What specialties typically use this device?
Neonatology, pediatrics, and maternity care professionals commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in maintaining a stable thermal environment for patients, especially infants, who cannot regulate their own body temperature.
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.