QGH · Class II · 21 CFR 882.5940

FDA Product Code QGH: Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

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.

Leading manufacturers include Mecta Corp. and Mecta Corporation.

9
Total
9
Cleared
198d
Avg days
1984
Since

FDA 510(k) Cleared Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder Devices (Product Code QGH)

9 devices
1–9 of 9
Cleared Apr 26, 2020
MECTA Sigma
K192834
Mecta Corporation
Neurology · 207d
Cleared Mar 06, 1997
SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.
K965070
Mecta Corp.
Neurology · 85d
Cleared Sep 18, 1996
SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M
K960754
Mecta Corp.
Neurology · 208d

About Product Code QGH - Regulatory Context