Device Classification Name |
Monitor, Extracellular Fluid, Lymphedema, Extremity
|
510(k) Number |
K220557 |
Device Name |
MoistureMeterD Compact, LymphScanner |
Applicant |
Delfin Technologies Ltd |
Microkatu 1 |
Kuopio,
FI
70210
|
|
Applicant Contact |
Jouni Nuutinen |
Correspondent |
F Care Systems USA (dba: Delfin USA LLC) |
11098 Biscayne Blvd, Suite 301 |
Miami,
FL
33161
|
|
Correspondent Contact |
Patrick Danciu |
Regulation Number | 870.2770
|
Classification Product Code |
|
Date Received | 02/28/2022 |
Decision Date | 05/27/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|