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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
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