The following data is part of a premarket notification filed by Impedimed Pty Ltd. with the FDA for Impedimed Extra Cellular Fluid Analysis, Model L-dex U400.
| Device ID | K080825 |
| 510k Number | K080825 |
| Device Name: | IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 |
| Classification | Monitor, Extracellular Fluid, Lymphedema, Extremity |
| Applicant | IMPEDIMED PTY LTD. UNIT 1, 50 PARKER COURT Pinkenba, Qld, AU 4008 |
| Contact | Philip S Auckland |
| Correspondent | Philip S Auckland IMPEDIMED PTY LTD. UNIT 1, 50 PARKER COURT Pinkenba, Qld, AU 4008 |
| Product Code | OBH |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-24 |
| Decision Date | 2008-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B277292U400CD2 | K080825 | 000 |