Clearance Summary
NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE received FDA 510(k) clearance under submission number K023016, 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 2002-12-04.
- Submission: K023016
- Applicant / Sponsor: Nicore Equipment & Leasing, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5225
- Decision date: 2002-12-04
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.