Clearance Summary
DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) received FDA 510(k) clearance under submission number K950314, sponsored by Dantec Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1996-03-25.
- Submission: K950314
- Applicant / Sponsor: Dantec Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1350
- Decision date: 1996-03-25
Classification & Regulation
This clearance is catalogued under FDA product code GXZ and 21 CFR 882.1350, within the Neurology review panel as a Class II device.