Clearance Summary
E-CLIP received FDA 510(k) clearance under submission number K900982, sponsored by Joel Cohen & Esther R. Cohen. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1990-04-19.
- Submission: K900982
- Applicant / Sponsor: Joel Cohen & Esther R. Cohen
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3680
- Decision date: 1990-04-19
Classification & Regulation
This clearance is catalogued under FDA product code LDF and 21 CFR 870.3680, within the Cardiovascular review panel as a Class II device.