Clearance Summary
NR5000 E.C.G. AND PULSE OXIMETER MONITOR received FDA 510(k) clearance under submission number K894919, 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 1989-09-18.
- Submission: K894919
- Applicant / Sponsor: Nirad , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 1989-09-18
Classification & Regulation
This clearance is catalogued under FDA product code DRT and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.