Clearance Summary
NEURO N 50 LESION GENERATOR received FDA 510(k) clearance under submission number K896450, sponsored by Leibinger & Fischer , 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 1991-03-19.
- Submission: K896450
- Applicant / Sponsor: Leibinger & Fischer , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4400
- Decision date: 1991-03-19
Classification & Regulation
This clearance is catalogued under FDA product code GXD and 21 CFR 882.4400, within the Neurology review panel as a Class II device.