K143310 is an FDA 510(k) clearance for the MoisturemeterD. 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 November 19, 2015, 366 days after receiving the submission on November 18, 2014.
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 | K143310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2014 |
| Decision Date | November 19, 2015 |
| Days to Decision | 366 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) |