FDA 510(k) Application Details - K233631

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

  More FDA Info for this Device
510(K) Number K233631
Device Name Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant Revital Lab Inc.
2349 Aragon Canyon St
Las Vegas, NV 89135 US
Other 510(k) Applications for this Company
Contact Conway Ho
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 11/13/2023
Decision Date 02/09/2024
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

FDA Source Information for K233631


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