G.Tec Medical Engineering GmbH is one of 30 FDA 510(k) medical device manufacturers from Austria in the dataset, ranked by real submission volume.
G.Tec Medical Engineering GmbH - FDA 510(k) Cleared Devices
Recent clearances: g.Estim FES, cortiQ PRO, g.Estim PRO
6
Total
6
Cleared
0
Denied
G.Tec Medical Engineering GmbH has 6 FDA 510(k) cleared medical devices. Based in Schiedlberg, AT.
Historical record: 6 cleared submissions from 2006 to 2020. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by G.Tec Medical Engineering GmbH Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Tuv Sud America, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - G.Tec Medical Engineering GmbH
6 devices