Clearance Summary
ICTA received FDA 510(k) clearance under submission number K120260, sponsored by 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 2012-06-29.
- Submission: K120260
- Applicant / Sponsor: Excel-Tech Ltd. (Xltek)
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2012-06-29
Classification & Regulation
This clearance is catalogued under FDA product code OMB and 21 CFR 882.1400, within the Neurology review panel as a Class II device.