Impedimed - Bis Extra Cellular Fluid Analysis
FDA 510(k) K130338 · ImpediMed Limited
510(k) numberK130338
Submission
- Device name
- Impedimed - Bis Extra Cellular Fluid Analysis
- Applicant
- ImpediMed Limited
Washington, DC, US - Received
- February 11, 2013
- Decision date
- May 31, 2013
- Decision
- Substantially Equivalent (SESE)
- 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)
Other 510(k)s with product code OBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K100811 | Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400OBH · Traditional | ImpediMed Limited | 11/04/2011SE |
| K080825 | Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400OBH · Traditional | Impedimed Pty , Ltd. | 10/03/2008SESK |
| 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 - Bis Extra Cellular Fluid Analysis cleared by the FDA?
Impedimed - Bis Extra Cellular Fluid Analysis (K130338) received a 510(k) decision of Substantially Equivalent on May 31, 2013, 109 days after the submission was received.
What is the product code of K130338?
The FDA product code is OBH – Monitor, Extracellular Fluid, Lymphedema, Extremity, a Class II (moderate risk) device regulated under 21 CFR 870.2770.