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 K083639
Device Name MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
9900 INNOVATION DR.
WAUWATOSA,  WI  53226
Applicant Contact LARRY LEPLEY
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
9900 INNOVATION DR.
WAUWATOSA,  WI  53226
Correspondent Contact LARRY LEPLEY
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/09/2008
Decision Date 02/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-