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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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
De Novo Number DEN070003
510(K) Number K061053
Device Name NEUROSTAR TMS SYSTEM
Requester
neuronetics
one great valley pkwy.
suite 2
malvern,  PA  19355
Contact judy p ways
Regulation Number882.5805
Classification Product Code
OBP  
Date Received05/24/2007
Decision Date 10/07/2008
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
-
-