Device Classification Name |
stimulator, transcutaneous electrical, aesthetic purposes
|
510(k) Number |
K230459 |
Device Name |
C.C. Life 21 |
Applicant |
21 Equipment S.R.L. |
Piazza Bodoni 3 |
Torino,
IT
10123
|
|
Applicant Contact |
Dolores Moretto |
Correspondent |
21 Equipment S.R.L. |
Piazza Bodoni 3 |
Torino,
IT
10123
|
|
Correspondent Contact |
Dolores Moretto |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 02/21/2023 |
Decision Date | 10/19/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|