This resource provides a comprehensive overview of the FDA clearance process for over-the-counter (OTC) medical devices, highlighting its importance in ensuring public safety, effectiveness, and regulatory compliance.
Pulse oximetry is a noninvasive method for measuring a patient’s oxygen level (SpO2) and heart rate. In short, it’s a simple, painless way to determine how effectively oxygen is being transferred to different parts of the body and how often the heart is beating.
A pulse oximeter is a small, lightweight device used to monitor the amount of oxygen carried in the body. This noninvasive tool attaches painlessly to your fingertip, sending two wavelengths of light through the finger to measure your pulse rate and how much oxygen is in your system.
Your blood oxygen level indicates how much oxygen your red blood cells are carrying. High blood oxygenation plays an essential role in ensuring that your muscles, brain and other organs receive the energy they need to function properly.