K220557 is an FDA 510(k) clearance for the MoistureMeterD Compact, LymphScanner. This device is classified as a Monitor, Extracellular Fluid, Lymphedema, Extremity (Class II - Special Controls, product code OBH).
Submitted by Delfin Technologies, Ltd. (Kuopio, FI). The FDA issued a Cleared decision on May 27, 2022, 88 days after receiving the submission on February 28, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 870.2770. 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).
| 510(k) Number | K220557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2022 |
| Decision Date | May 27, 2022 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OBH - Monitor, Extracellular Fluid, Lymphedema, Extremity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |
| Definition | 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) |