The following data is part of a premarket notification filed by Impedimed Pty Ltd. with the FDA for Impedimed-extracellular Fluid Analysis.
| Device ID | K050415 |
| 510k Number | K050415 |
| Device Name: | IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS |
| Classification | Monitor, Extracellular Fluid, Lymphedema, Extremity |
| Applicant | IMPEDIMED PTY LTD. BUILDING 4B/2404 LOGAN ROAD EIGHT MILE PLAINS Brisbane, Queensland, AU 4113 |
| Contact | Neville Bertwistle |
| Correspondent | Neville Bertwistle IMPEDIMED PTY LTD. BUILDING 4B/2404 LOGAN ROAD EIGHT MILE PLAINS Brisbane, Queensland, AU 4113 |
| Product Code | OBH |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-18 |
| Decision Date | 2007-03-30 |
| Summary: | summary |