• 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, Diagnostic Radiology
510(k) Number K141428
Device Name MDMC-12133
Applicant
BARCO N.V.
35 PRESIDENT KENNEDYPARK
KORTRIJK,  BE 8500
Applicant Contact LIEVEN DE WANDEL
Correspondent
BARCO N.V.
35 PRESIDENT KENNEDYPARK
KORTRIJK,  BE 8500
Correspondent Contact LIEVEN DE WANDEL
Regulation Number892.2050
Classification Product Code
PGY  
Date Received05/30/2014
Decision Date 06/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-