Clearance Summary
IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 received FDA 510(k) clearance under submission number K100811, sponsored by ImpediMed Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-11-04.
- Submission: K100811
- Applicant / Sponsor: ImpediMed Limited
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2011-11-04
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.