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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 K911144
FOIA Releasable 510(k) K911144
Device Name MF-500, MODIFICATION
14 EAST 60TH ST.
NEW YORK,  NY  10022
Applicant Contact IVAN G SCHICK
14 EAST 60TH ST.
NEW YORK,  NY  10022
Correspondent Contact IVAN G SCHICK
Regulation Number882.5940
Classification Product Code
Date Received02/25/1991
Decision Date 10/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No