FDA 510(k) Application Details - K991054

Device Classification Name Electroencephalograph

  More FDA Info for this Device
510(K) Number K991054
Device Name Electroencephalograph
Applicant NICOLET BIOMEDICAL, INC.
5225 VERONA RD.
MADISON, WI 53711 US
Other 510(k) Applications for this Company
Contact DOUGLAS E PFRANG
Other 510(k) Applications for this Contact
Regulation Number 882.1400

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

  More FDA Info for this Product Code
Date Received 03/30/1999
Decision Date 11/03/1999
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