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 Display, Cathode-Ray Tube, Medical
510(k) Number K122167
Device Name NEXXIS OR
Applicant
Barco N.V.
35 President Kennedypark
Kortrijk,  BE
Applicant Contact LIEVEN DE WANDEL
Correspondent
Barco N.V.
35 President Kennedypark
Kortrijk,  BE
Correspondent Contact LIEVEN DE WANDEL
Regulation Number870.2450
Classification Product Code
DXJ  
Date Received07/23/2012
Decision Date 04/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-