Clearance Summary
INFUSION PUMP & IV SETS #4000 received FDA 510(k) clearance under submission number K832755, sponsored by Omni-Glow, Inc.. 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 1983-11-03.
- Submission: K832755
- Applicant / Sponsor: Omni-Glow, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1983-11-03
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.