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510(k) K911144

MF-500, MODIFICATION by Elcot, Inc. — Product Code QGH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1991
Date Received
February 25, 1991
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.

  • K863815 — ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000 (June 2, 1987)

Other clearances for product code QGH

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  • 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)
  • K863815 — ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000 (June 2, 1987)
  • 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)