Panels › Cardiovascular › Product code OBH · Class 2
Monitor, Extracellular Fluid, Lymphedema, Extremity
Regulation 870.2770
1510(k)s in 12 months (10 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OBH
| Company | 510(k)s | Recalls |
|---|---|---|
| ImpediMed Limited | 8 | 1 |
| Delfin Technologies, Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 28, 2026 | K253224 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) ImpediMed Limited, AU | OBH |
| May 4, 2023 | K230530 | SOZO Pro ImpediMed Limited, AU | OBH |
| May 27, 2022 | K220557 | MoistureMeterD Compact, LymphScanner Delfin Technologies, Ltd., FI | OBH |
| Apr 16, 2018 | K180126 | SOZO ImpediMed Limited, AU | OBH |
| Aug 11, 2017 | K172122 | SOZO ImpediMed Limited, AU | OBH |
| Nov 19, 2015 | K143310 | MoisturemeterD Delfin Technologies, Ltd., FI | OBH |
| May 31, 2013 | K130338 | IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS ImpediMed Limited | OBH |
| Nov 4, 2011 | K100811 | IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 ImpediMed Limited | OBH |
| Oct 3, 2008 | K080825 | IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 Impedimed Pty , Ltd., AU | OBH |
| Mar 30, 2007 | K050415 | IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS Impedimed Pty , Ltd., AU | OBH |
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