The following data is part of a premarket notification filed by Somatics, Inc. with the FDA for Thymatron 2000 Electroconvulsive System.
| Device ID | K945120 |
| 510k Number | K945120 |
| Device Name: | THYMATRON 2000 ELECTROCONVULSIVE SYSTEM |
| Classification | Device, Electroconvulsive Therapy |
| Applicant | SOMATICS, INC. 910 SHERWOOD DR., UNIT 17 Lake Bluff, IL 60044 |
| Contact | Richard Abrams |
| Correspondent | Richard Abrams SOMATICS, INC. 910 SHERWOOD DR., UNIT 17 Lake Bluff, IL 60044 |
| Product Code | GXC |
| CFR Regulation Number | 882.5940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-19 |
| Decision Date | 1995-10-26 |