The following data is part of a premarket notification filed by Delfin Technologies Ltd. with the FDA for Moisturemeterd.
| Device ID | K143310 |
| 510k Number | K143310 |
| Device Name: | MoisturemeterD |
| Classification | Monitor, Extracellular Fluid, Lymphedema, Extremity |
| Applicant | DELFIN TECHNOLOGIES LTD. MICROKATU 1 Kudpio, FI 70210 |
| Contact | Theodore Sullivan |
| Correspondent | Theodore Sullivan BUCHANAN INGERSOL AND ROONEY 1700 K STREET, N.W. SUITE 300 Washington, DC 20006 -3807 |
| Product Code | OBH |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-18 |
| Decision Date | 2015-11-19 |
| Summary: | summary |