FDA 510(k) Application Details - K961642

Device Classification Name Electroencephalograph

  More FDA Info for this Device
510(K) Number K961642
Device Name Electroencephalograph
Applicant OXFORD INSTRUMENTS, PLC.
11526 53RD ST. N.
CLEARWATER, FL 34620 US
Other 510(k) Applications for this Company
Contact CHARLES HOLZ
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 04/29/1996
Decision Date 01/17/1997
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