Clearance Summary
IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS received FDA 510(k) clearance under submission number K130338, 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 2013-05-31.
- Submission: K130338
- Applicant / Sponsor: ImpediMed Limited
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2013-05-31
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.