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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K030129
Device Name MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
Applicant
Endocardial Solutions, Inc.
1350 Energy Ln., Suite 110
St. Paul,  MN  55108
Applicant Contact KAREN J MCKELVEY
Correspondent
Endocardial Solutions, Inc.
1350 Energy Ln., Suite 110
St. Paul,  MN  55108
Correspondent Contact KAREN J MCKELVEY
Regulation Number870.1425
Classification Product Code
DQK  
Date Received01/14/2003
Decision Date 04/22/2003
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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