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 Stimulator, Electrical, Evoked Response
510(k) Number K190703
Device Name Neuro-IOM system with Neuro-IOM.NET software
Applicant
Neurosoft Ltd
5, Voronin str.
Ivanovo,  RU 153032
Applicant Contact Eugene Polezhaev
Correspondent
Makromed, Inc.
88 Stiles Road
Salem,  NH  03079
Correspondent Contact Barry V Ashar
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
GWE   GWJ   OLT   PDQ  
Date Received03/18/2019
Decision Date 05/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-