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oximetry interface kit
Philips Respironics
Summary: The oximetry interface kit by Philips Respironics is a medical device used to monitor oxygen saturation levels in patients. It is primarily used by healthcare professionals in various clinical settings.
FDA Clearance Information
Pathway
510K
Number
K111378 ↗
Decision Date
October 4, 2011
Product Code
MNS
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on October 4, 2011. It is manufactured by Philips Respironics and classified as a Class 2 medical device.
What It Is
The oximetry interface kit is a medical device designed to measure and monitor oxygen saturation levels in the blood. It functions by using sensors that detect the amount of oxygen carried by hemoglobin in the blood. This information is crucial for assessing a patient's respiratory function and is commonly used in conjunction with other vital sign monitoring systems.
Clinical Applications
This device is commonly used in hospitals, outpatient clinics, and home healthcare settings. It is particularly useful in specialties such as pulmonology, critical care, and anesthesiology, where continuous monitoring of a patient's oxygen levels is essential. It serves a wide range of patient populations, including those with respiratory conditions, undergoing surgery, or requiring long-term oxygen therapy.
Indications for Use
The FDA indications for this device focus on its use in monitoring oxygen saturation levels in patients. It is intended for individuals who need continuous or spot-check monitoring of their blood oxygen levels, such as those with chronic respiratory diseases or during surgical procedures.
Practical Considerations
The oximetry interface kit is typically compatible with various monitoring systems and can be used with standard finger clip sensors. Clinicians should ensure proper sensor placement and calibration for accurate readings. The device is generally easy to use and integrates well into existing monitoring setups.
Related Literature
The linked study describes a web-based vital sign telemonitor that includes the use of an oximetry development kit for monitoring oxygen saturation. The study highlights the system's ability to acquire and display vital signs over the internet, making it useful for telemedicine applications. However, the study's design was limited to a prototype system and did not include clinical trials to validate its effectiveness in real-world settings.
Frequently Asked Questions
What is the oximetry interface kit used for?
It is used to monitor and measure oxygen saturation levels in patients' blood, providing crucial information for assessing respiratory function.
What specialties typically use this device?
Specialties such as pulmonology, critical care, anesthesiology, and home healthcare commonly use this device.
What are the FDA-cleared indications?
The device is cleared for monitoring oxygen saturation levels in patients, useful for those with respiratory conditions or undergoing surgery.
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.