Clearance Summary
EMPOWERMR INJECTOR SYSTEM, MODEL 9730 received FDA 510(k) clearance under submission number K062449, sponsored by E-Z-Em, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-04-13.
- Submission: K062449
- Applicant / Sponsor: E-Z-Em, Inc.
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 2007-04-13
Classification & Regulation
This clearance is catalogued under FDA product code IZQ and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.