Clearance Summary
SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES received FDA 510(k) clearance under submission number K895604, sponsored by Medical Design & Manufacturing 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 1989-10-13.
- Submission: K895604
- Applicant / Sponsor: Medical Design & Manufacturing Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 1989-10-13
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.