XL Tek Evoked Potential Headbox, Model EP-16
by Excel Tech., Ltd. 510(k)
Active
510(k) K992313
Overview
The device is an Electrical Stimulator, Evoked Response, used for neurological monitoring. It functions as an interface for capturing and assessing a patient's neurological status during surgical procedures or long-term ICU monitoring.
It is supplied for use in operating rooms and critical care settings. The device has FDA 510(k) clearance under K992313, is classified as Class II with product code GWF, and was determined substantially equivalent on August 19, 1999.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992313 | Date19 Aug 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- 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
Other devices from Excel Tech., Ltd.
Questions
What is the XL TEK EP-16 evoked potential headbox used for?
The XL TEK EP-16 is an electrical stimulator for evoked response, used to capture and assess a patient's neurological status during surgical procedures or long-term ICU monitoring, serving as an interface for neurological data acquisition in critical care environments.
How is the XL TEK EP-16 supplied and where is it intended for use?
The device is supplied for use in operating rooms and critical care settings, functioning as an interface for neurological monitoring during surgeries or extended ICU stays, designed to interface with patient monitoring systems to capture evoked potentials.
What regulatory clearance does the XL TEK EP-16 have and what is its classification?
The XL TEK EP-16 has FDA 510(k) clearance under K992313, is classified as a Class II medical device with product code GWF, and was determined substantially equivalent on August 19, 1999, based on its traditional 510(k) submission.