Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K093566 |
Device Name |
CARTO XP EP NAVIGATION SYSTEM, VERSION 10 |
Applicant |
BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. |
DIAMOND BAR,
CA
91765
|
|
Applicant Contact |
WAYNE R HOHMAN |
Correspondent |
BIOSENSE WEBSTER, INC. |
3333 DIAMOND CANYON RD. |
DIAMOND BAR,
CA
91765
|
|
Correspondent Contact |
WAYNE R HOHMAN |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 11/18/2009 |
Decision Date | 06/18/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|