Clearance Summary
INTRAVENOUS INFUSION PUMP received FDA 510(k) clearance under submission number K771300, sponsored by Stewart-Naumann Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1977-12-08.
- Submission: K771300
- Applicant / Sponsor: Stewart-Naumann Laboratories
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1977-12-08
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.