Xltek Protektor Stimulator, Models 10247 & 10248

• • Terminated Z-1068-2015 FDA Class II ·initiated 2 Jan 2015

  Software error occurs when using remote monitoring; if the remote user tries to stop the free run waveform group, the system will display a message informing the user that they do not have sufficient privilege.

510(k) Number

K040358 ↗

FDA Product Code

GWF

FDA applicant

Excel Tech. , Ltd.

Device Class

Class II

Regulation

21 CFR Part 882.1870

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Excel Tech., Ltd. →