The following data is part of a premarket notification filed by Impedimed Limited with the FDA for Impedimed - Extracellular Fluid Analyzer Model: L-dex U400.
| Device ID | K100811 |
| 510k Number | K100811 |
| Device Name: | IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 |
| Classification | Monitor, Extracellular Fluid, Lymphedema, Extremity |
| Applicant | IMPEDIMED LIMITED 5959 CORNERSTONE COURT WEST SUITE 100 San Diego, CA 92121 |
| Contact | Alden Kay |
| Correspondent | Alden Kay IMPEDIMED LIMITED 5959 CORNERSTONE COURT WEST SUITE 100 San Diego, CA 92121 |
| Product Code | OBH |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-22 |
| Decision Date | 2011-11-04 |
| Summary: | summary |