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510(k) K192834

MECTA Sigma by Mecta Corporation — Product Code QGH

K192834 is an FDA 510(k) premarket notification submitted by Mecta Corporation for the device "MECTA Sigma". The FDA issued a decision of Substantially Equivalent on April 26, 2020. The device falls under product code QGH (Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder), a Class II device regulated under 21 CFR 882.5940. Mecta Corporation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2020
Date Received
October 2, 2019
Clearance Type
Special
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 Mecta Corporation

  • K201309 — ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium (June 4, 2021)

Other clearances for product code QGH

  • 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)
  • 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)

FDA data resources