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 cuff, nerve
510(k) Number K180222
Device Name Reaxon Plus
Applicant
Medovent GmbH
Friedrich-Koenig-Str. 3
Mainz,  DE 55129
Applicant Contact Peter Meier
Correspondent
Medovent GmbH
Friedrich-Koenig-Str. 3
Mainz,  DE 55129
Correspondent Contact Peter Meier
Regulation Number882.5275
Classification Product Code
JXI  
Date Received01/25/2018
Decision Date 04/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-