FDA 510(k) Application Details - K041263

Device Classification Name Normalizing Quantitative Electroencephalograph Software

  More FDA Info for this Device
510(K) Number K041263
Device Name Normalizing Quantitative Electroencephalograph Software
Applicant APPLIED NEUROSCIENCE INC.
228 176TH TERRACE DRIVE
ST. PETERSBURG, FL 33708 US
Other 510(k) Applications for this Company
Contact ROBERT W THATCHER
Other 510(k) Applications for this Contact
Regulation Number 882.1400

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

  More FDA Info for this Product Code
Date Received 05/11/2004
Decision Date 08/03/2004
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