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FDA 510(k), K192834, MECTA Sigma
FDA 510(k), K192834, MECTA Sigma
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510(K) Number: K192834
Device Name: MECTA Sigma
Manufacturer: Mecta Corporation
Device Classification Name: Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
Regulation Number: 882.5940
Classification Product Code: QGH
Date Received: 10/02/2019
Decision Date: 04/26/2020
Regulation Medical Specialty: Neurology
Device Name: MECTA Sigma
Manufacturer: Mecta Corporation
Device Classification Name: Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
Regulation Number: 882.5940
Classification Product Code: QGH
Date Received: 10/02/2019
Decision Date: 04/26/2020
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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