510(k) K945120
- Device
- THYMATRON 2000 ELECTROCONVULSIVE SYSTEM
- Applicant
- SOMATICS, INC.
- 510(k) number
- K945120
- Product code
- GXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-10-26
- Date received
- 1994-10-19
- Regulation
- 882.5940
- Classification name
- Device, Electroconvulsive Therapy
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD ABRAMS
- Address
- 910 Sherwood Dr., Unit 17 Lake Bluff IL US 60044 60044
FDA Registration Numbers#
- 3023869663
- 1420295
Source Documents#
Legacy Summary#
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FDA Review#
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