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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 K965070
Device Name SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M.
Applicant
MECTA CORP.
7015 S.W. MC EWAN RD.
LAKE OSWEGO,  OR  97035
Applicant Contact ROBIN H NICOL
Correspondent
MECTA CORP.
7015 S.W. MC EWAN RD.
LAKE OSWEGO,  OR  97035
Correspondent Contact ROBIN H NICOL
Regulation Number882.5940
Classification Product Code
QGH  
Date Received12/11/1996
Decision Date 03/06/1997
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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