Clearance Summary
TELEFACTOR D/EEG-32 received FDA 510(k) clearance under submission number K925838, sponsored by Grass-Telefactor Product Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1993-04-30.
- Submission: K925838
- Applicant / Sponsor: Grass-Telefactor Product Group
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 1993-04-30
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.