Clearance Summary
IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 received FDA 510(k) clearance under submission number K080825, 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 2008-10-03.
- Submission: K080825
- Applicant / Sponsor: Impedimed Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2008-10-03
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.