Clearance Summary
DISPOSABLE MONOPLAR MEDDLE ELECTRODES received FDA 510(k) clearance under submission number K915741, 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 1992-12-08.
- Submission: K915741
- Applicant / Sponsor: Dantec Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4600
- Decision date: 1992-12-08
Classification & Regulation
This clearance is catalogued under FDA product code GXE and 21 CFR 882.4600, within the Neurology review panel as a Class I device.