Clearance Summary
MOBILE I.V. SYSTEMS 10,20,60 received FDA 510(k) clearance under submission number K080695, sponsored by Northwind Technologies, Corp.. 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 2008-07-01.
- Submission: K080695
- Applicant / Sponsor: Northwind Technologies, Corp.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2008-07-01
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.