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 computer, diagnostic, programmable
510(k) Number K002869
Device Name LOCALISA CARDIAC NAVIGATION SYSTEM
Applicant
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
3850 VICTORIA ST. NORTH
SHOREVIEW,  MN  55126
Applicant Contact THOMAS PARKER
Correspondent
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
3850 VICTORIA ST. NORTH
SHOREVIEW,  MN  55126
Correspondent Contact THOMAS PARKER
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/13/2000
Decision Date 03/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-