Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K093455 |
Device Name |
CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES |
Applicant |
BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. |
DIAMOND BAR,
CA
91765
|
|
Applicant Contact |
Balaka Das |
Correspondent |
BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. |
DIAMOND BAR,
CA
91765
|
|
Correspondent Contact |
Balaka Das |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 11/05/2009 |
Decision Date | 12/04/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|