510(k) K860467
- Device
- ELECTROSHOCK UNIT NEUROLOGY MODEL B-25
- Applicant
- MEDCRAFT CORP.
- 510(k) number
- K860467
- Product code
- QGH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-11-10
- Date received
- 1986-02-06
- Regulation
- 882.5940
- Classification name
- Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHYUNG
- Address
- 433 Boston Post Rd. Darien CT US 06820 06820
FDA Registration Numbers#
- 3023869663
- 1420295
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QGH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192834 | MECTA Sigma | Mecta Corporation | 2020-04-26 |
| K965070 | SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M. | Mecta Corp. | 1997-03-06 |
| K960754 | SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M | Mecta Corp. | 1996-09-18 |
| K945120 | THYMATRON 2000 ELECTROCONVULSIVE SYSTEM | Somatics, Inc. | 1995-10-26 |
| K911144 | MF-500, MODIFICATION | Elcot, Inc. | 1991-10-18 |
| K863815 | ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000 | Elcot, Inc. | 1987-06-02 |
| K852069 | MECTA ECT DEVICE MODELS SR & JR | Mecta Corp. | 1985-08-09 |
| K843923 | THYMATRON | Somatics, Inc. | 1984-12-03 |
Legacy Summary#
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FDA Review#
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