Clearance Summary
Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) received FDA 510(k) clearance under submission number K153193, sponsored by Zyno Medical, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2016-08-30.
- Submission: K153193
- Applicant / Sponsor: Zyno Medical, LLC
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2016-08-30
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.