Clearance Summary
NOBLES-LAI ENGINEERING INFUSION PUMP received FDA 510(k) clearance under submission number K895688, sponsored by Nobles-Lai Engineering, 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 1990-02-26.
- Submission: K895688
- Applicant / Sponsor: Nobles-Lai Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1800
- Decision date: 1990-02-26
Classification & Regulation
This clearance is catalogued under FDA product code DQI and 21 CFR 870.1800, within the Cardiovascular review panel as a Class II device.