FDA Product Code
FDA Product Code OBH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2770
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253224 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | ImpediMed Limited | 2026-01-28 | Traditional | PDF ↗ |
| K230530 | SOZO Pro | ImpediMed Limited | 2023-05-04 | Special | PDF ↗ |
| K220557 | MoistureMeterD Compact, LymphScanner | Delfin Technologies, Ltd. | 2022-05-27 | Traditional | PDF ↗ |
| K180126 | SOZO | ImpediMed Limited | 2018-04-16 | Traditional | PDF ↗ |
| K172122 | SOZO | ImpediMed Limited | 2017-08-11 | Special | PDF ↗ |
| K143310 | MoisturemeterD | Delfin Technologies, Ltd. | 2015-11-19 | Traditional | PDF ↗ |
| K130338 | IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS | ImpediMed Limited | 2013-05-31 | Traditional | PDF ↗ |
| K100811 | IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 | ImpediMed Limited | 2011-11-04 | Traditional | PDF ↗ |
| K080825 | IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 | Impedimed Pty , Ltd. | 2008-10-03 | Traditional | PDF ↗ |
| K050415 | IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS | Impedimed Pty , Ltd. | 2007-03-30 | Traditional | PDF ↗ |
Product code OBH · Class II · Cardiovascular. Data: openFDA.