FDA 510(k) Application Details - K023949

Device Classification Name Neurological Stereotaxic Instrument

  More FDA Info for this Device
510(K) Number K023949
Device Name Neurological Stereotaxic Instrument
Applicant IMAGE-GUIDED NEUROLOGICS, INC.
2290 W. EAU GALLIE BLVD.
SUITE 210
MELBOURNE, FL 32935 US
Other 510(k) Applications for this Company
Contact DAVID M LEE
Other 510(k) Applications for this Contact
Regulation Number 882.4560

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

  More FDA Info for this Product Code
Date Received 11/27/2002
Decision Date 02/25/2003
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