FDA 510(k) Application Details - K955577

Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software

  More FDA Info for this Device
510(K) Number K955577
Device Name Non-Normalizing Quantitative Electroencephalograph Software
Applicant STELLATE SYSTEMS
345 VICTORIA AVE., SUITE 505
WESTMOUNT, QUEBEC,
CANADA, H32 2N2 CA
Other 510(k) Applications for this Company
Contact GEORGE PAPAGIANNIS
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 11/08/1995
Decision Date 09/20/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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