Clearance Summary
M AND R REUSABLE ELECTRODES (MULTIPLE) received FDA 510(k) clearance under submission number K963125, 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 1997-02-06.
- Submission: K963125
- Applicant / Sponsor: M & R Mfg., Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1997-02-06
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.