FDA 510(k) Application Details - K220177

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

  More FDA Info for this Device
510(K) Number K220177
Device Name Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant Magnus Medical, Inc.
1350 Old Bayshore Highway
Suite 600
Burlingame, CA 94010 US
Other 510(k) Applications for this Company
Contact Brett Wingeier
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 01/21/2022
Decision Date 09/01/2022
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