FDA 510(k) Applications Submitted by ENDOCARDIAL SOLUTIONS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K983456 |
09/30/1998 |
ENSITE 3000 SYSTEM |
ENDOCARDIAL SOLUTIONS, INC. |
| K001437 |
05/08/2000 |
ENSITE 3000 SYSTEM, MODEL EE3000 |
ENDOCARDIAL SOLUTIONS, INC. |
| K012926 |
08/31/2001 |
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 |
ENDOCARDIAL SOLUTIONS, INC. |
| K993376 |
10/07/1999 |
ENSTYLET MODELS EC0010, EC0020 |
ENDOCARDIAL SOLUTIONS, INC. |
| K992479 |
07/26/1999 |
ENSITE 3000 SYSTEM |
ENDOCARDIAL SOLUTIONS, INC. |
| K030129 |
01/14/2003 |
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 |
ENDOCARDIAL SOLUTIONS, INC. |
| K042493 |
09/14/2004 |
ENSITE SYSTEM, MODEL EE3000 |
ENDOCARDIAL SOLUTIONS, INC. |
| K033211 |
10/03/2003 |
ENSITE SYSTEM |
ENDOCARDIAL SOLUTIONS, INC. |
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