FDA 510(k) Application Details - K123902

Device Classification Name Electromyograph, Diagnostic

  More FDA Info for this Device
510(K) Number K123902
Device Name Electromyograph, Diagnostic
Applicant OKTX LLC
7225 S 85TH E AVE.
SUITE 300
TULSA, OK 74137 US
Other 510(k) Applications for this Company
Contact MARY ROSE C REASTON
Other 510(k) Applications for this Contact
Regulation Number 890.1375

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

  More FDA Info for this Product Code
Date Received 12/18/2012
Decision Date 09/13/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
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