MoisturemeterD
FDA 510(k) K143310 · Delfin Technologies, Ltd.
510(k) numberK143310
Submission
- Device name
- MoisturemeterD
- Applicant
- Delfin Technologies, Ltd.
Kuopio, FI - Received
- November 18, 2014
- Decision date
- November 19, 2015
- 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)
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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 |
| 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 |
| 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 |
|---|---|---|
| K220557 | MoistureMeterD Compact, LymphScannerOBH · Traditional | 05/27/2022SE |
Questions and answers
When was MoisturemeterD cleared by the FDA?
MoisturemeterD (K143310) received a 510(k) decision of Substantially Equivalent on November 19, 2015, 366 days after the submission was received.
What is the product code of K143310?
The FDA product code is OBH – Monitor, Extracellular Fluid, Lymphedema, Extremity, a Class II (moderate risk) device regulated under 21 CFR 870.2770.