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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 K863815
FOIA Releasable 510(k) K863815
Device Name ELECTROCONVULSIVE THERAPY DEVICE, MODEL MF-1000
Applicant
ELCOT, INC.
14 EAST 60TH ST.
NEW YORK,  NY  10022
Applicant Contact IVAN G SCHICK
Correspondent
ELCOT, INC.
14 EAST 60TH ST.
NEW YORK,  NY  10022
Correspondent Contact IVAN G SCHICK
Regulation Number882.5940
Classification Product Code
QGH  
Date Received09/30/1986
Decision Date 06/02/1987
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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