FDA 510(k), K945120, THYMATRON 2000 ELECTROCONVULSIVE SYSTEM
FDA 510(k), K945120, THYMATRON 2000 ELECTROCONVULSIVE SYSTEM
| 510(k) Number | K945120 |
| Device Classification Name | Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder |
| Device Name | THYMATRON 2000 ELECTROCONVULSIVE SYSTEM |
| Applicant | Somatics, Inc. 910 Sherwood Dr., Unit 17 Lake Bluff, IL 60044 |
| Regulation Number | 882.594 |
| Classification Product Code | QGH |
| Date Received | 10/19/1994 |
| Decision Date | 10/26/1995 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Neurology |
| 510k Review Panel | Neurology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 563 |
| Redacted Pages | 256 |
| Unredacted Pages | 307 |
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