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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
510(k) Number K192834
Device Name MECTA Sigma
Applicant
Mecta Corporation
19799 SW 95th Ave.
Suite B,  OR  97062
Applicant Contact Robin Nicol
Correspondent
Mecta Corporation
19799 SW 95th Ave.
Suite B,  OR  97062
Correspondent Contact Robin Nicol
Regulation Number882.5940
Classification Product Code
QGH  
Date Received10/02/2019
Decision Date 04/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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