Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name transcranial magnetic stimulator
510(k) Number K213543
Device Name NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
Applicant
Neuronetics, Inc
3222 Phoenixville Pike
Malvern,  PA  19355
Applicant Contact Fred Cowdery
Correspondent
Neuronetics, Inc
3222 Phoenixville Pike
Malvern,  PA  19355
Correspondent Contact Fred Cowdery
Regulation Number882.5805
Classification Product Code
OBP  
Date Received11/08/2021
Decision Date 12/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-