FDA 510(k) Application Details - K023536

Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software

  More FDA Info for this Device
510(K) Number K023536
Device Name Non-Normalizing Quantitative Electroencephalograph Software
Applicant NEUROSCAN
7850 PASEO DEL NORTE
SUITE 101
EL PASO, TX 79912 US
Other 510(k) Applications for this Company
Contact ELVIRA GARCIA
Other 510(k) Applications for this Contact
Regulation Number 882.1400

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

  More FDA Info for this Product Code
Date Received 10/21/2002
Decision Date 01/15/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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