Clearance Summary
M & R DISPOSABLE ELECTRODE (14200) received FDA 510(k) clearance under submission number K963236, sponsored by M & R Mfg., 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 1996-11-15.
- Submission: K963236
- Applicant / Sponsor: M & R Mfg., Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 1996-11-15
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.