Description
The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), is seeking sources for a commercial Electrosurgical Unit (ESU) and all required accessories. The ESU will be used to generate electromagnetic disturbance signals that emulate real-world exposure conditions in support of laboratory experiments, test method development, and verification activities. The system shall include a touchscreen user interface, real-time tissue impedance monitoring, output frequency between 400 kHz and 500 kHz, and support monopolar, bipolar, and vessel-sealing operating modes.
The key requirements of this opportunity include:
• The equipment shall be new, unused, fully operational upon delivery, and meet all technical and functional requirements specified in the Requirements Document.
• The acquisition includes all accessories necessary for full operation, user and technical documentation, a minimum one-year manufacturer's warranty, and delivery within 60 calendar days after contract award.
• The anticipated quantity is one (1) complete system, including all accessories, documentation, and warranty required by the Requirements Document.