K100811 is an FDA 510(k) clearance for the IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400. This device is classified as a Monitor, Extracellular Fluid, Lymphedema, Extremity (Class II - Special Controls, product code OBH).
Submitted by ImpediMed Limited (San Diego, US). The FDA issued a Cleared decision on November 4, 2011, 592 days after receiving the submission on March 22, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770. 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).
| 510(k) Number | K100811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2010 |
| Decision Date | November 04, 2011 |
| Days to Decision | 592 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OBH - Monitor, Extracellular Fluid, Lymphedema, Extremity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |
| Definition | 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) |