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 K014108
Device Name MAC 5000 ECG ANALYSIS SYSTEM
Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Applicant Contact LISA LEE MICHELS
Correspondent
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
8200 WEST TOWER AVE.
MILWAUKEE,  WI  53223
Correspondent Contact LISA LEE MICHELS
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/13/2001
Decision Date 01/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-