Safe Bvm Corporation

Safe Bvm Corporation specializes in non-powered airway pressure monitors. These devices are designed to measure and display pressure within airway devices, specifically for respiratory support applications. The company’s portfolio includes devices like the Adult Sotair Device and the Sotair Device, which focus on monitoring airway pressure without requiring external power sources.

Safe Bvm Corporation is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance context, particularly when reviewing its device listings and submissions.

Safe Bvm Corporation’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries are used to track and verify the authorization status of medical devices in the United States, ensuring transparency and compliance with regulatory requirements.

Safe Bvm Corporation’s devices, such as the Sotair and Adult Sotair, are classified as Class II under regulatory frameworks. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, beyond general controls.