Pacificmd Biotech, LLC

Pacificmd Biotech, LLC specializes in computerized rhinomanometers, such as the VISIONAIR device. These devices measure nasal airflow resistance and obstruction, which are critical for clinical assessment of nasal function and sinus health.

Pacificmd Biotech, LLC is based in the United States. Since the company operates within the US, its devices are subject to FDA regulations, including submissions to the 510(k) and UDI registries, which track device authorizations and compliance.

The devices produced by Pacificmd Biotech, LLC are classified as Class II under US regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

The devices manufactured by Pacificmd Biotech, LLC are listed in the FDA’s 510(k) and UDI registries. The 510(k) process demonstrates substantial equivalence to a predicate device, while the UDI system ensures unique identification and traceability of medical devices throughout their lifecycle.