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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 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 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
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