Emergency use authorizations SLS medical has received Emergency Use Authorization (EUA) from the FDA for use of certain SLS medical devices to treat patients during the COVID-19 pandemic. Pursuant to the EUA, a fact sheet for healthcare providers has been issued to outline the significant known and potential risks, as well as benefits, associated with the emergency use of ventilators. The fact sheet for patients must be provided to patients using EUA ventilator devices and contains information to help them understand the risks and benefits associated with using ventilators for their treatment.
SLS Medical Technology Corp., Ltd. Model CP101/CP101S has been approved by US FDA EUA (Emergency Use of Authorization) process as the ventilator that meets the applicable conditions and criteria for safety, performance and labeling set forth in Section II, Section IV, and Appendix A of EUA Letter, to support the COVID-19 pandemic. (https://www.fda.gov/media/136528/download") or search "authorized ventilators" and find "download" file.
For product details, please contact SLS Medical Technology Corp., Ltd. as following information: