FDA 510(k) Application Details - K031999

Device Classification Name Neurological Stereotaxic Instrument

  More FDA Info for this Device
510(K) Number K031999
Device Name Neurological Stereotaxic Instrument
Applicant ELEKTA INSTRUMENT AB
BIRGER JARLSGATAN 53
STOCKHOLM S-103-93 SE
Other 510(k) Applications for this Company
Contact PETER LOWENDAHL
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 06/27/2003
Decision Date 07/25/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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