
| FDA 510(k) clearance |
We are glad to announce that we have been granted clearance by the U.S. Food and Drug Administration to market our WaveGuard EEG caps for routine clinical use. The FDA 510(k) is the logical addition to the already CE marked WaveGuard caps. The official US assessment included safety and performance aspects, and effectively results in the use of our caps in conjunction with different EEG acquisition systems. This extends the benefits of using these caps to more physicians for many different recording purposes in a clinical environment. WaveGuard caps are the latest and most advanced caps available at the moment. The advances in cap design are made possible through the use of lightweight, flexible and sintered Ag/AgCl material that can be easily used with a variety of head shapes, allowing easier application of the caps and comfortable recordings. The option to use shielded wires is available with the caps for even better recording results. more | ![]() |
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