FDA 510(k) Application Details - K201910

Device Classification Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph

  More FDA Info for this Device
510(K) Number K201910
Device Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
Applicant Neurologic LLC
6500 Tucker Avenue
McLean, VA 22101 US
Other 510(k) Applications for this Company
Contact Sridevi Sarma
Other 510(k) Applications for this Contact
Regulation Number 882.1400

  More FDA Info for this Regulation Number
Classification Product Code OLX
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 07/09/2020
Decision Date 12/22/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact