Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400
FDA 510(k) K080825 · Impedimed Pty , Ltd.
510(k) numberK080825
Submission
- Device name
- Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400
- Applicant
- Impedimed Pty , Ltd.
Pinkenba, Qld, AU - Received
- March 24, 2008
- Decision date
- October 3, 2008
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBH – Monitor, Extracellular Fluid, Lymphedema, Extremity
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2770
- Specialty
- Cardiovascular
Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity)
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| K253224 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)OBH · Traditional | ImpediMed Limited | 01/28/2026SE |
| K230530 | SOZO ProOBH · Special | ImpediMed Limited | 05/04/2023SE |
| K220557 | MoistureMeterD Compact, LymphScannerOBH · Traditional | Delfin Technologies, Ltd. | 05/27/2022SE |
| K180126 | SozoOBH · Traditional | ImpediMed Limited | 04/16/2018SE |
| K172122 | SozoOBH · Special | ImpediMed Limited | 08/11/2017SE |
| K143310 | MoisturemeterDOBH · Traditional | Delfin Technologies, Ltd. | 11/19/2015SE |
| K130338 | Impedimed - Bis Extra Cellular Fluid AnalysisOBH · Traditional | ImpediMed Limited | 05/31/2013SE |
| K100811 | Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400OBH · Traditional | ImpediMed Limited | 11/04/2011SE |
| K050415 | Impedimed-Extracellular Fluid AnalysisOBH · Traditional | Impedimed Pty , Ltd. | 03/30/2007SESK |
More from Impedimed Pty , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)DSB · Traditional | 08/17/2026SE |
| K253224 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)OBH · Traditional | 01/28/2026SE |
| K232089 | SOZO ProDSB · Traditional | 10/17/2023SE |
| K230531 | SOZO ProQJB · Special | 05/04/2023SE |
| K230530 | SOZO ProOBH · Special | 05/04/2023SE |
| K203473 | SozoDSB · Traditional | 04/19/2021SE |
| K193410 | SOZO Body Fluid AnalyzerDSB · Traditional | 10/02/2020SE |
| K190529 | SozoQJB · Traditional | 11/25/2019SE |
| K180126 | SozoOBH · Traditional | 04/16/2018SE |
| K172507 | SozoDSB · Traditional | 12/22/2017SE |
Questions and answers
When was Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 cleared by the FDA?
Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 (K080825) received a 510(k) decision of Unknown on October 3, 2008, 193 days after the submission was received.
What is the product code of K080825?
The FDA product code is OBH – Monitor, Extracellular Fluid, Lymphedema, Extremity, a Class II (moderate risk) device regulated under 21 CFR 870.2770.