Clearance Summary
TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET received FDA 510(k) clearance under submission number K001461, sponsored by Biometrix , Ltd.. 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 2000-09-11.
- Submission: K001461
- Applicant / Sponsor: Biometrix , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5025
- Decision date: 2000-09-11
Classification & Regulation
This clearance is catalogued under FDA product code KPE and 21 CFR 880.5025, within the General Hospital review panel as a Class II device.