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510(k) K863815

ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000 by Elcot, Inc. — Product Code QGH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1987
Date Received
September 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
Device Class
Class II
Regulation Number
882.5940
Review Panel
NE
Submission Type

Catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.

Other clearances by Elcot, Inc.

  • K911144 — MF-500, MODIFICATION (October 18, 1991)

Other clearances for product code QGH

  • K192834 — MECTA Sigma (April 26, 2020)
  • K965070 — SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M. (March 6, 1997)
  • K960754 — SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M (September 18, 1996)
  • K945120 — THYMATRON 2000 ELECTROCONVULSIVE SYSTEM (October 26, 1995)
  • K911144 — MF-500, MODIFICATION (October 18, 1991)
  • K860467 — ELECTROSHOCK UNIT NEUROLOGY MODEL B-25 (November 10, 1986)
  • K852069 — MECTA ECT DEVICE MODELS SR & JR (August 9, 1985)
  • K843923 — THYMATRON (December 3, 1984)