Clearance Summary
NR2000 CARDIAC MONITOR received FDA 510(k) clearance under submission number K883903, sponsored by Nirad , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1989-03-09.
- Submission: K883903
- Applicant / Sponsor: Nirad , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 1989-03-09
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.