Clearance Summary
SMARTez elastomeric infusion pump received FDA 510(k) clearance under submission number K151650, sponsored by Epic Medical Pte. , 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 2016-04-04.
- Submission: K151650
- Applicant / Sponsor: Epic Medical Pte. , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2016-04-04
Classification & Regulation
This clearance is catalogued under FDA product code MEB and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.