Clearance Summary
SOLO MICROPUMP INSULIN DELIVERY SYSTEM received FDA 510(k) clearance under submission number K093364, sponsored by Medingo , 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 2010-01-25.
- Submission: K093364
- Applicant / Sponsor: Medingo , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2010-01-25
Classification & Regulation
This clearance is catalogued under FDA product code LZG and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.