• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name computer, diagnostic, programmable
510(k) Number K120301
Model MG1000
Device Name MEDIGUIDE TECHNOLOGY
Original Applicant
ST. JUDE MEDICAL, MEDIGUIDE NAVIGATION SYSTEMS
columbia square
555 thirteenth, nw
washington,  DC  20004 1109
Original Contact jonathan s kahan
Regulation Number870.1425
Classification Product Code
DQK  
Date Received01/31/2012
Decision Date 02/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-