Fingertip Pulse Oximeter

The MD300C208 Fingertip Pulse Oximeter is designed to monitor oxygen saturation (SpO₂) and pulse rate in real time. It uses photoplethysmography to detect blood volume changes and light absorption differences between oxygenated and deoxygenated hemoglobin. This makes it useful for assessing respiratory and circulatory function in both clinical and home settings, such as during patient care, anesthesia, or at-home health monitoring.

The device is supplied as a standalone unit. Sensors for this model can be either disposable or reusable, depending on the manufacturer’s guidelines. No additional sterilization is required beyond following the manufacturer’s instructions for the chosen sensor type. Always verify the sensor compatibility and usage instructions provided with the device.

The MD300C208 Fingertip Pulse Oximeter itself is a reusable device, but its sensors can be either single-use or reusable. The manufacturer specifies whether sensors should be discarded after one use or cleaned and reused. Always adhere to the manufacturer’s guidelines to ensure accuracy, hygiene, and device longevity.

The device holds FDA clearance under the 510(k) pathway, specifically with the clearance number K151206. This clearance confirms that the device is substantially equivalent to a predicate device and complies with U.S. medical device standards. The clearance was granted by the FDA’s Cardiovascular Advisory Committee, ensuring its safety and effectiveness for the intended use.

The device’s storage conditions and shelf life are not explicitly detailed in the provided data. However, it is critical to follow the manufacturer’s instructions for storage to maintain the device’s accuracy and functionality. Improper storage could compromise performance or sensor reliability, so always refer to the accompanying documentation or contact the manufacturer for specific guidance.