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 K152993
Device Name MUSE Cardiology Information System
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
9900 WEST INNOVATION DRIVE
WAUWATOSA,  WI  53226
Applicant Contact AMY YANG
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
9900 WEST INNOVATION DRIVE
WAUWATOSA,  WI  53226
Correspondent Contact AMY YANG
Regulation Number870.1425
Classification Product Code
DQK  
Date Received10/13/2015
Decision Date 01/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-