Clearance Summary
IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS received FDA 510(k) clearance under submission number K050415, sponsored by Impedimed Pty , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-03-30.
- Submission: K050415
- Applicant / Sponsor: Impedimed Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2007-03-30
Classification & Regulation
This clearance is catalogued under FDA product code OBH and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.