MECTA Sigma

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

Mecta Corporation

The following data is part of a premarket notification filed by Mecta Corporation with the FDA for Mecta Sigma.

Pre-market Notification Details

Device IDK192834
510k NumberK192834
Device Name:MECTA Sigma
ClassificationElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
Applicant Mecta Corporation 19799 SW 95th Ave. Tualatin,  OR  97062
ContactRobin Nicol
CorrespondentRobin Nicol
MECTA Corporation 19799 SW 95th Ave Tualatin,  OR  97062
Product CodeQGH  
CFR Regulation Number882.5940 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-02
Decision Date2020-04-26

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