Clearance Summary
TRACE RITE SOLID GEL ECG ELECTRODES received FDA 510(k) clearance under submission number K964213, sponsored by Bio-Detek, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1996-11-25.
- Submission: K964213
- Applicant / Sponsor: Bio-Detek, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1996-11-25
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.