ABYSSAL, K.K.

Abyssal, K.K. specializes in electrocardiography (ECG) monitoring system receivers. These devices are designed for continuous or intermittent cardiac rhythm analysis, supporting both clinical and ambulatory monitoring applications. The focus is on systems that help track heart activity for diagnostic purposes.

Abyssal, K.K. is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available data.

Abyssal, K.K.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance for Class II medical devices, including ECG monitoring systems, under U.S. regulatory requirements.

Abyssal, K.K.’s devices fall under the FDA’s Class II classification. This classification is assigned based on the level of risk associated with the device, where Class II devices require special controls in addition to general controls to ensure safety and effectiveness, such as ECG monitoring systems.

The FDA’s UDI database is relevant because it provides a standardized way to identify Abyssal, K.K.’s ECG monitoring system receivers uniquely. This helps in tracking devices throughout their lifecycle, ensuring proper labeling, recall management, and compliance with regulatory requirements for Class II devices.