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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 K852069
FOIA Releasable 510(k) K852069
Device Name MECTA ECT DEVICE MODELS SR & JR
Applicant
Mecta Corp.
122 Southeast Ave.
8th. Ave. #A
Portland,  OR  97214
Applicant Contact REX HIATT
Correspondent
Mecta Corp.
122 Southeast Ave.
8th. Ave. #A
Portland,  OR  97214
Correspondent Contact REX HIATT
Regulation Number882.5940
Classification Product Code
QGH  
Date Received05/10/1985
Decision Date 08/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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