FDA 510(k) Application Details - K180369

Device Classification Name Probe, Radiofrequency Lesion

  More FDA Info for this Device
510(K) Number K180369
Device Name Probe, Radiofrequency Lesion
Applicant Relievant Medsystems
385 Moffett Park Drive, Suite 105
Sunnyvale, CA 94089 US
Other 510(k) Applications for this Company
Contact Alex DiNello
Other 510(k) Applications for this Contact
Regulation Number 882.4725

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

  More FDA Info for this Product Code
Date Received 02/12/2018
Decision Date 09/14/2018
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