• 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 electrocardiograph
510(k) Number K120770
Device Name QT GUARD PLUS ANALYSIS SYSTEM
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
9900 innovation drive
wauwatosa,  WI  53226
Applicant Contact kristin pabst
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
9900 innovation drive
wauwatosa,  WI  53226
Correspondent Contact kristin pabst
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Code
MLC  
Date Received03/14/2012
Decision Date 12/06/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-