The following data is part of a premarket notification filed by Impedimed Pty Ltd. with the FDA for Impedimed - Body Composition Analysis.
| Device ID | K050395 |
| 510k Number | K050395 |
| Device Name: | IMPEDIMED - BODY COMPOSITION ANALYSIS |
| Classification | Analyzer, Body Composition |
| Applicant | IMPEDIMED PTY LTD. BUILDING 4B/2404 LOGAN ROAD EIGHT MILE PLAINS Brisbane, Queensland, AU 4113 |
| Contact | Nevelli Bertwistle |
| Correspondent | Nevelli Bertwistle IMPEDIMED PTY LTD. BUILDING 4B/2404 LOGAN ROAD EIGHT MILE PLAINS Brisbane, Queensland, AU 4113 |
| Product Code | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-16 |
| Decision Date | 2005-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B277292DF50CD1 | K050395 | 000 |
| B277259DF502 | K050395 | 000 |
| B277253DF502 | K050395 | 000 |
| B277249DF502 | K050395 | 000 |
| B277243DF502 | K050395 | 000 |
| B277229DF502 | K050395 | 000 |
| B277223DF502 | K050395 | 000 |