SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M

Device, Electroconvulsive Therapy

MECTA CORP.

The following data is part of a premarket notification filed by Mecta Corp. with the FDA for Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M.

Pre-market Notification Details

• Device ID: K960754
• 510k Number: K960754
• Device Name: SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M
• Classification: Device, Electroconvulsive Therapy
• Applicant: MECTA CORP. 7015 S.W. MC EWAN RD. Lake Oswego, OR 97035
• Contact: Robin H Nicol
• Correspondent: Robin H Nicol; MECTA CORP. 7015 S.W. MC EWAN RD. Lake Oswego, OR 97035
• Product Code: GXC
• CFR Regulation Number: 882.5940 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-02-23
• Decision Date: 1996-09-18
• Summary: summary