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510(k) K192834

Device
MECTA Sigma
Applicant
Mecta Corporation
510(k) number
K192834
Product code
QGH  
Decision
Substantially Equivalent (SESE)
Decision date
2020-04-26
Date received
2019-10-02
Regulation
882.5940
Classification name
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Robin Nicol
Address
19799 SW 95th Ave. Suite B OR US 97062 97062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code QGH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K965070SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.Mecta Corp.1997-03-06
K960754SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 MMecta Corp.1996-09-18
K945120THYMATRON 2000 ELECTROCONVULSIVE SYSTEMSomatics, Inc.1995-10-26
K911144MF-500, MODIFICATIONElcot, Inc.1991-10-18
K863815ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000Elcot, Inc.1987-06-02
K860467ELECTROSHOCK UNIT NEUROLOGY MODEL B-25Medcraft Corp.1986-11-10
K852069MECTA ECT DEVICE MODELS SR & JRMecta Corp.1985-08-09
K843923THYMATRONSomatics, Inc.1984-12-03

Legacy Summary#

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FDA Review#

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