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FDA 510(k), K030129, MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
FDA 510(k), K030129, MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
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510(K) Number: K030129
Device Name: MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
Manufacturer: ENDOCARDIAL SOLUTIONS, INC.
Device Classification Name: computer, diagnostic, programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 01/14/2003
Decision Date: 04/22/2003
Regulation Medical Specialty: Cardiovascular
Device Name: MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
Manufacturer: ENDOCARDIAL SOLUTIONS, INC.
Device Classification Name: computer, diagnostic, programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 01/14/2003
Decision Date: 04/22/2003
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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