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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 K960754
Device Name SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M
Applicant
Mecta Corp.
7015 SW Mc Ewan Rd.
Lake Oswego,  OR  97035
Applicant Contact ROBIN H NICOL
Correspondent
Mecta Corp.
7015 SW Mc Ewan Rd.
Lake Oswego,  OR  97035
Correspondent Contact ROBIN H NICOL
Regulation Number882.5940
Classification Product Code
QGH  
Date Received02/23/1996
Decision Date 09/18/1996
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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