Product code QGH

Device name: Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
Medical specialty: Neurology
Device class: 2
Regulation number: 882.5940
Review panel: NE
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: 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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
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
K860467	ELECTROSHOCK UNIT NEUROLOGY MODEL B-25	Medcraft Corp.	1986-11-10
K852069	MECTA ECT DEVICE MODELS SR & JR	Mecta Corp.	1985-08-09
K843923	THYMATRON	Somatics, Inc.	1984-12-03

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