The following data is part of a premarket notification filed by Impedimed Pty Ltd. with the FDA for Impedimed - Body Composition Analyzer, Model Imp Sfb7.
| Device ID | K052319 |
| 510k Number | K052319 |
| Device Name: | IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7 |
| Classification | Analyzer, Body Composition |
| 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 | MNW |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-25 |
| Decision Date | 2006-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B277299SFB7CD1 | K052319 | 000 |
| B277293SFB7CD0 | K052319 | 000 |
| B277259SFB72 | K052319 | 000 |
| B277253SBF72 | K052319 | 000 |
| B277249SFB70 | K052319 | 000 |
| B277243SFB72 | K052319 | 000 |
| B277229SFB72 | K052319 | 000 |
| B277223SFB72 | K052319 | 000 |