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The NEURESCUE device has received FDA 510(k) Clearance for sale in the US from the U.S. Food and Drug Administration (K210358) for the following Indications for Use: The NEURESCUE device is intended for temporary occlusion of large vessels and monitoring of blood pressure, including patients requiring emergency control of hemorrhage. The use of said 510(k) cleared devices shall strictly follow the labeling provided with said devices and the use of these devices shall not be based on the text or images provided on the Website. The NEURESCUE Device has received FDA IDE Approval for cardiac arrest. The use of the Investigational Device under the FDA IDE Approval is limited by Federal Law to Investigational Use.
The NEURESCUE device does not have regulatory clearance from a notified body (EU).
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