MoistureMeterD Compact, LymphScanner
FDA 510(k) K220557 · Delfin Technologies, Ltd.
510(k) numberK220557
Submission
- Device name
- MoistureMeterD Compact, LymphScanner
- Applicant
- Delfin Technologies, Ltd.
Kuopio, FI - Received
- February 28, 2022
- Decision date
- May 27, 2022
- 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 |
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| 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 |
| 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 |
|---|---|---|
| K143310 | MoisturemeterDOBH · Traditional | 11/19/2015SE |
Questions and answers
When was MoistureMeterD Compact, LymphScanner cleared by the FDA?
MoistureMeterD Compact, LymphScanner (K220557) received a 510(k) decision of Substantially Equivalent on May 27, 2022, 88 days after the submission was received.
What is the product code of K220557?
The FDA product code is OBH – Monitor, Extracellular Fluid, Lymphedema, Extremity, a Class II (moderate risk) device regulated under 21 CFR 870.2770.