Pulmone Advanced Medical Devices, Ltd.

Pulmone Advanced Medical Devices, Ltd. specializes in professional diagnostic spirometers and pulmonary function analysis systems for adult use. These devices include portable and compact models, such as the MiniBox series, which measure key lung function parameters like airflow, volume, and spirometry metrics. They are designed for clinical and research environments to evaluate respiratory health and aid in diagnosing lung-related conditions.

Pulmone Advanced Medical Devices, Ltd. is based in the United States. Its devices are authorised under the FDA’s regulatory framework, specifically listed in the 510(k) premarket notification program and the UDI (Unique Device Identification) system. These registries ensure traceability and compliance with US medical device requirements.

Pulmone’s devices fall under FDA Class II classification, which means they pose moderate risk and require special controls to ensure safety and effectiveness. This classification requires manufacturers to follow specific regulatory pathways, such as the 510(k) process, to demonstrate that their devices are substantially equivalent to legally marketed predicates. Class II classification helps balance oversight with innovation while ensuring patient safety in diagnostic and monitoring applications.

Pulmone’s devices are listed in the FDA’s 510(k) registry, which tracks premarket notifications for Class II medical devices, and the FDA’s UDI system, which assigns unique identifiers to devices for better tracking and compliance. These registries help ensure transparency and adherence to US medical device regulations.