Device Classification Name |
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
|
510(k) Number |
K192834 |
Device Name |
MECTA Sigma |
Applicant |
Mecta Corporation |
19799 SW 95th Ave. |
Tualatin,
OR
97062
|
|
Applicant Contact |
Robin Nicol |
Correspondent |
MECTA Corporation |
19799 SW 95th Ave |
Tualatin,
OR
97062
|
|
Correspondent Contact |
Robin Nicol |
Regulation Number | 882.5940
|
Classification Product Code |
|
Date Received | 10/02/2019 |
Decision Date | 04/26/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|