FDA 510(k), K060954, MODIFICATION TO ENSITE SYSTEM, MODEL EE3000

FDA 510(k), K060954, MODIFICATION TO ENSITE SYSTEM, MODEL EE3000

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510(K) Number: K060954
Device Name: MODIFICATION TO ENSITE SYSTEM, MODEL EE3000
Manufacturer: ST. JUDE MEDICAL, INC.-ENDOCARDIAL SOLUTIONS
Device Classification Name: computer, diagnostic, programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 04/07/2006
Decision Date: 04/21/2006
Regulation Medical Specialty: Cardiovascular

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