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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 K945120
FOIA Releasable 510(k) K945120
Device Name THYMATRON 2000 ELECTROCONVULSIVE SYSTEM
Applicant
Somatics, Inc.
910 Sherwood Dr., Unit 17
Lake Bluff,  IL  60044
Applicant Contact RICHARD ABRAMS
Correspondent
Somatics, Inc.
910 Sherwood Dr., Unit 17
Lake Bluff,  IL  60044
Correspondent Contact RICHARD ABRAMS
Regulation Number882.5940
Classification Product Code
QGH  
Date Received10/19/1994
Decision Date 10/26/1995
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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