Clearance Summary
Volumetric Infusion Controller received FDA 510(k) clearance under submission number K153760, sponsored by DEKA Research & Development. 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 2016-10-03.
- Submission: K153760
- Applicant / Sponsor: DEKA Research & Development
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2016-10-03
Classification & Regulation
This clearance is catalogued under FDA product code LDR and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.