FDA 510(k) Application Details - K080678

Device Classification Name Neurological Stereotaxic Instrument

  More FDA Info for this Device
510(K) Number K080678
Device Name Neurological Stereotaxic Instrument
Applicant BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN 85622 DE
Other 510(k) Applications for this Company
Contact PER PERSSON
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 03/10/2008
Decision Date 06/06/2008
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