Clearance Summary
ANODYNE II-ELECTRICAL NEURO STIMULATOR received FDA 510(k) clearance under submission number K761053, sponsored by Rich-Mar Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1976-11-30.
- Submission: K761053
- Applicant / Sponsor: Rich-Mar Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1976-11-30
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.