Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K091789 |
Device Name |
CARTO RMT EP NAVIGATION SYSTEM V8 |
Applicant |
BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. |
DIAMOND BAR,
CA
91765
|
|
Applicant Contact |
DIANA THORSON |
Correspondent |
BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. |
DIAMOND BAR,
CA
91765
|
|
Correspondent Contact |
DIANA THORSON |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 06/17/2009 |
Decision Date | 10/01/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|