Clearance Summary
Trex_HD received FDA 510(k) clearance under submission number K162595, sponsored by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2016-11-04.
- Submission: K162595
- Applicant / Sponsor: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2016-11-04
Classification & Regulation
This clearance is catalogued under FDA product code GWQ and 21 CFR 882.1400, within the Neurology review panel as a Class II device.