FDA 510(k) Application Details - K100126

Device Classification Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph

  More FDA Info for this Device
510(K) Number K100126
Device Name Neuroimaging Correlation Software For Electroencephalograph Or Magnetoencephalograph
Applicant EXCEL-TECH LTD. (XLTEK)
2568 BRISTOL CIR.
OAKVILLE, ONTARIO L6H 5S1 CA
Other 510(k) Applications for this Company
Contact GOLDY SINGH
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 01/19/2010
Decision Date 12/03/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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