• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name electroconvulsive therapy device for catatonia, major depressive disorder, and bipolar disorder
510(k) Number K192834
Device Name MECTA Sigma
Mecta Corporation
19799 SW 95th Ave.
Tualatin,  OR  97062
Applicant Contact Robin Nicol
MECTA Corporation
19799 SW 95th Ave
Tualatin,  OR  97062
Correspondent Contact Robin Nicol
Regulation Number882.5940
Classification Product Code
Date Received10/02/2019
Decision Date 04/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No