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FloPatch Indications for Use

FloPatch FP120 gained regulatory clearance from the FDA in March 2020 under 510(k) number K200337.

FloPatch is indicated for use for the non-invasive assessment of blood flow in the carotid artery. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode, and is not capable of operating in any other mode.

The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use on adults only.