The following data is part of a premarket notification filed by Delfin Technologies Ltd with the FDA for Moisturemeterd Compact, Lymphscanner.
| Device ID | K220557 |
| 510k Number | K220557 |
| Device Name: | MoistureMeterD Compact, LymphScanner |
| Classification | Monitor, Extracellular Fluid, Lymphedema, Extremity |
| Applicant | Delfin Technologies Ltd Microkatu 1 Kuopio, FI 70210 |
| Contact | Jouni Nuutinen |
| Correspondent | Patrick Danciu F Care Systems USA (dba: Delfin USA LLC) 11098 Biscayne Blvd, Suite 301 Miami, FL 33161 |
| Product Code | OBH |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-28 |
| Decision Date | 2022-05-27 |