FDA 510(k) Application Details - K042208

Device Classification Name Electrode, Depth

  More FDA Info for this Device
510(K) Number K042208
Device Name Electrode, Depth
Applicant INOMED MEDIZINTECHNIK GMBH
KUNGSTENSGATAN 18, PO BX 7593
STOCKHOLM SE-103 93 DE
Other 510(k) Applications for this Company
Contact ANDERS SKOGLUND
Other 510(k) Applications for this Contact
Regulation Number 882.1330

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

  More FDA Info for this Product Code
Date Received 08/16/2004
Decision Date 03/18/2005
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