Senzime submits 510 (k) application to the FDA
Uppsala, September 25, 2017. Senzime AB (publ) announced today that the company has submitted a 510 (k) application to the US Food and Drug Administration (FDA) for approval of the TetraGraph in the United States.This FDA application is part of Senzime's launch plan for the TetraGraph, with primary focus of launching in Europe, Japan and the United States - central markets for monitoring patients undergoing surgery with general anesthesia and muscle relaxants. The approval is expected within 12-15 months. "We are in the final stage regarding CE marking for TetraGraph and OnZurf probe.