Clearance Summary
GEL ELECTRODE received FDA 510(k) clearance under submission number K813176, sponsored by Dyn-A-Med Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1981-12-29.
- Submission: K813176
- Applicant / Sponsor: Dyn-A-Med Products
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1981-12-29
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.