MECTA Sigma

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

Mecta Corporation

The following data is part of a premarket notification filed by Mecta Corporation with the FDA for Mecta Sigma.

Pre-market Notification Details

• Device ID: K192834
• 510k Number: K192834
• Device Name: MECTA Sigma
• Classification: Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
• Applicant: Mecta Corporation 19799 SW 95th Ave. Tualatin, OR 97062
• Contact: Robin Nicol
• Correspondent: Robin Nicol; MECTA Corporation 19799 SW 95th Ave Tualatin, OR 97062
• Product Code: QGH
• CFR Regulation Number: 882.5940 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-10-02
• Decision Date: 2020-04-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850045508012	K192834	000