Clearance Summary
XLTEK EMU40 EEG HEADBOX, MODEL PK1072 received FDA 510(k) clearance under submission number K053386, sponsored by Excel Tech. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2006-04-21.
- Submission: K053386
- Applicant / Sponsor: Excel Tech. , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2006-04-21
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.