SPECTRUM 5000 Q, 5000Q,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, 5000q,m,4000 Q, 4000 M..

Pre-market Notification Details

• Device ID: K965070
• 510k Number: K965070
• Device Name: SPECTRUM 5000 Q, 5000Q,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: 1996-12-11
• Decision Date: 1997-03-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00861539000134	K965070	000
00861539000127	K965070	000
00861539000110	K965070	000
00861539000103	K965070	000