510(k) K100811
K100811 is an FDA 510(k) premarket notification submitted by ImpediMed Limited for the device "IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400". The FDA issued a decision of Substantially Equivalent on November 4, 2011. The device falls under product code OBH (Monitor, Extracellular Fluid, Lymphedema, Extremity), a Class II device regulated under 21 CFR 870.2770. ImpediMed Limited has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 2011
- Date Received
- March 22, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Extracellular Fluid, Lymphedema, Extremity
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- GU
- Submission Type
Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity)