Clearance Summary
Imed Technology Intravascular Administration Set, Imed Technology Extension Set received FDA 510(k) clearance under submission number K150513, sponsored by Imed Technology, Inc.. 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 2015-05-28.
- Submission: K150513
- Applicant / Sponsor: Imed Technology, Inc.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2015-05-28
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.