Clearance Summary
NICORE MODEL ESP -1 received FDA 510(k) clearance under submission number K980937, sponsored by Nicore Equipment & Leasing, 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 2000-09-15.
- Submission: K980937
- Applicant / Sponsor: Nicore Equipment & Leasing, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5225
- Decision date: 2000-09-15
Classification & Regulation
This clearance is catalogued under FDA product code DRN and 21 CFR 870.5225, within the Cardiovascular review panel as a Class II device.