Device Type: Cardiovascular - Monitoring
FDA Description:
A pulse oximeter is a Class II medical device that non-invasively measures blood oxygen saturation (SpO₂) and pulse rate. It uses light absorption through a finger, earlobe, or other tissue to provide real-time readings. The FDA regulates pulse oximeters under strict safety and performance standards.
General Description:
A pulse oximeter is a compact, non-invasive medical device that measures a patient’s blood oxygen saturation (SpO₂) and pulse rate. Widely used in clinical and home settings, it provides real-time monitoring of oxygen levels, critical for patients with respiratory conditions, cardiovascular issues, or during surgical procedures.
The device operates by emitting light through a translucent body part, such as a fingertip or earlobe. It detects changes in light absorption by oxygenated and deoxygenated hemoglobin, calculating the percentage of oxygen saturation in the blood. Modern pulse oximeters feature digital displays, providing clear and immediate results.
Pulse oximeters are available in various forms, including handheld, tabletop, and fingertip models, offering portability and convenience. Advanced models may include alarms for abnormal readings, wireless connectivity for data sharing, and integration with patient monitoring systems.
These devices are essential in hospitals, emergency care, and home settings, especially for individuals with conditions such as COPD, asthma, or COVID-19. Pulse oximeters meet stringent FDA requirements to ensure accuracy, reliability, and safety. By providing continuous, non-invasive monitoring, they empower healthcare providers and patients to manage health conditions effectively and respond promptly to critical changes.