K192834 is an FDA 510(k) clearance for the MECTA Sigma. This device is classified as a Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder (Class II - Special Controls, product code QGH).
Submitted by Mecta Corporation (Suite B, US). The FDA issued a Cleared decision on April 26, 2020, 207 days after receiving the submission on October 2, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5940. Catatonia Or A Severe Major Depressive Episode (mde) Associated With Major Depressive Disorder (mdd) Or Bipolar Disorder (bpd) In Patients Age 13 Years And Older Who Are Treatment-resistant Or Who Require A Rapid Response Due To The Severity Of Their Psychiatric Or Medical Condition..
| 510(k) Number | K192834 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2019 |
| Decision Date | April 26, 2020 |
| Days to Decision | 207 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | QGH - Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5940 |
| Definition | Catatonia Or A Severe Major Depressive Episode (mde) Associated With Major Depressive Disorder (mdd) Or Bipolar Disorder (bpd) In Patients Age 13 Years And Older Who Are Treatment-resistant Or Who Require A Rapid Response Due To The Severity Of Their Psychiatric Or Medical Condition. |