510(k) K863815
- Device
- ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000
- Applicant
- ELCOT, INC.
- 510(k) number
- K863815
- Product code
- GXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-06-02
- Date received
- 1986-09-30
- Regulation
- 882.5940
- Classification name
- Device, Electroconvulsive Therapy
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- IVAN G SCHICK
- Address
- 14 E. 60th St. New York NY US 10022 10022
FDA Registration Numbers#
- 3023869663
- 1420295
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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