K945120 is an FDA 510(k) clearance for the THYMATRON 2000 ELECTROCONVULSIVE SYSTEM. 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 Somatics, Inc. (Lake Bluff, US). The FDA issued a Cleared decision on October 26, 1995, 372 days after receiving the submission on October 19, 1994.
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 | K945120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1994 |
| Decision Date | October 26, 1995 |
| Days to Decision | 372 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| 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. |