FDA 510(k) Application Details - K172667

Device Classification Name Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder

  More FDA Info for this Device
510(K) Number K172667
Device Name Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant Tonica Elektronik A/S
Lucernemarken 15
Farum 3520 DK
Other 510(k) Applications for this Company
Contact Lise Terkelsen
Other 510(k) Applications for this Contact
Regulation Number 882.5805

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

  More FDA Info for this Product Code
Date Received 09/05/2017
Decision Date 10/05/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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