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 Generator, Lesion, Radiofrequency
510(k) Number K111576
Device Name NT 2000 LESIONING GENERATOR
Applicant
Neuro Therm, Inc.
200 Homer Ave.,
Ashland,  MA  01721
Applicant Contact F. DAVID ROTHKOPF
Correspondent
Neuro Therm, Inc.
200 Homer Ave.,
Ashland,  MA  01721
Correspondent Contact F. DAVID ROTHKOPF
Regulation Number882.4400
Classification Product Code
GXD  
Date Received06/06/2011
Decision Date 09/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-